21 C.F.R. PART 868--ANESTHESIOLOGY DEVICES
TITLE 21--Food and Drugs
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 868--ANESTHESIOLOGY DEVICES
Subpart A--GENERAL PROVISIONS
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| Effective dates of requirement for premarket approval.
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| Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
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Subpart B--DIAGNOSTIC DEVICES
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| Arterial blood sampling kit.
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| Indwelling blood oxyhemoglobin concentration analyzer.
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| Indwelling blood carbon dioxide partial pressure (P) analyzer.
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| Indwelling blood hydrogen ion concentration (pH) analyzer.
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| Indwelling blood oxygen partial pressure (P) analyzer.
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| Carbon dioxide gas analyzer.
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| Carbon monoxide gas analyzer.
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| Nitrous oxide gas analyzer.
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| Inspiratory airway pressure meter.
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| Peak-flow meter for spirometry.
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| Pulmonary-function data calculator.
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| Predictive pulmonary-function value calculator.
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| Diagnostic pulmonary-function interpretation calculator.
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| Esophageal stethoscope with electrical conductors.
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Subpart C--MONITORING DEVICES
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| Ultrasonic air embolism monitor.
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| Uncompensated thorpe tube flowmeter.
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| Compensated thorpe tube flowmeter.
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| Gas calibration flowmeter.
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| Breathing frequency monitor.
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| Nitrogen dioxide analyzer.
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| Cutaneous carbon dioxide (PcCO2) monitor.
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| Cutaneous oxygen (PcO2) monitor.
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| Electrical peripheral nerve stimulator.
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| Differential pressure transducer.
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Subparts D-E--[RESERVED]
Subpart F--THERAPEUTIC DEVICES
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| Device to relieve acute upper airway obstruction.
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| Anesthesia conduction catheter.
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| Anesthesia conduction filter.
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| Anesthesia conduction kit.
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| Anesthesia conduction needle.
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| Gas machine for anesthesia or analgesia.
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| Nitric oxide administration apparatus.
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| Laryngotracheal topical anesthesia applicator.
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| Anesthesia breathing circuit.
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| Breathing circuit circulator.
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| Breathing circuit bacterial filter.
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| Carbon dioxide absorbent.
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| Posture chair for cardiac or pulmonary treatment.
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| Heat and moisture condenser (artificial nose).
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| Electroanesthesia apparatus.
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| Gas-scavenging apparatus.
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| Portable oxygen generator.
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| Respiratory gas humidifier.
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| Therapeutic humidifier for home use.
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| Membrane lung for long-term pulmonary support.
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| Medicinal nonventilatory nebulizer (atomizer).
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| Portable liquid oxygen unit.
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| Electrically powered oxygen tent.
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| Tracheal/bronchial differential ventilation tube.
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| Inflatable tracheal tube cuff.
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| Tracheal tube fixation device.
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| Tube introduction forceps.
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| Tracheal tube cleaning brush.
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| Tracheostomy tube and tube cuff.
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| Autotransfusion apparatus.
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| Pressure tubing and accessories.
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| Noncontinuous ventilator (IPPB).
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| Manual emergency ventilator.
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| Powered emergency ventilator.
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| External negative pressure ventilator.
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| Intermittent mandatory ventilation attachment.
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| Positive end expiratory pressure breathing attachment.
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Subpart G--MISCELLANEOUS
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| Anesthetic cabinet, table, or tray.
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| Cardiopulmonary emergency cart.
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| Tracheobronchial suction catheter.
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| Patient position support.
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| Medical gas yoke assembly.
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