21 C.F.R. PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES
TITLE 21--Food and Drugs
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 880--GENERAL HOSPITAL AND PERSONAL USE 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--[RESERVED]
Subpart C--GENERAL HOSPITAL AND PERSONAL USE MONITORING DEVICES
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| Liquid crystal forehead temperature strip.
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| Electronic monitor for gravity flow infusion systems.
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| Electrically powered spinal fluid pressure monitor.
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| Sterilization process indicator.
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| Clinical color change thermometer.
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| Clinical electronic thermometer.
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| Clinical mercury thermometer.
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Subparts D-E--[RESERVED]
Subpart F--GENERAL HOSPITAL AND PERSONAL USE THERAPEUTIC DEVICES
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| Medical recirculating air cleaner.
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| AC-powered adjustable hospital bed.
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| Hydraulic adjustable hospital bed.
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| Manual adjustable hospital bed.
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| Nonpowered flotation therapy mattress.
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| Therapeutic medical binder.
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| Intravascular catheter securement device.
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| Medical adhesive tape and adhesive bandage.
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| Neonatal transport incubator.
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| Pressure infusor for an I.V. bag.
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| Nonelectrically powered fluid injector.
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| Intravascular administration set.
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| Patient care reverse isolation chamber.
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| Non-AC-powered patient lift.
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| Alternating pressure air flotation mattress.
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| Temperature regulated water mattress.
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| Hypodermic single lumen needle.
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| Pediatric position holder.
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| Neonatal phototherapy unit.
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| Chemical cold pack snakebite kit.
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| Medical support stocking.
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| Therapeutic scrotal support.
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| Umbilical occlusion device.
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| Subcutaneous, implanted, intravascular infusion port and catheter.
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| Percutaneous, implanted, long-term intravascular catheter.
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Subpart G--GENERAL HOSPITAL AND PERSONAL USE MISCELLANEOUS DEVICES
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| Absorbent tipped applicator.
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| Medical disposable bedding.
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| Cardiopulmonary resuscitation board.
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| Ethylene oxide gas aerator cabinet.
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| Ultrasonic cleaner for medical instruments.
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| Mattress cover for medical purposes.
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| Patient examination glove.
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| Implantable radiofrequency transponder system for patient identification and health information.
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| AC-powered medical examination light.
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| Battery-powered medical examination light.
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| Liquid medication dispenser.
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| Skin pressure protectors.
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| Medical ultraviolet air purifier.
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| Medical ultraviolet water purifier.
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| Vacuum-powered body fluid suction apparatus.
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| Powered patient transfer device.
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| Manual patient transfer device.
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| Washers for body waste receptacles.
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| Medical disposable scissors.
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| Ethylene oxide gas sterilizer.
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| Liquid chemical sterilants/high level disinfectants.
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| General purpose disinfectants.
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| Syringe needle introducer.
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| Liquid crystal vein locator.
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| Medical washer-disinfector.
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