21 C.F.R. PART 882--NEUROLOGICAL DEVICES
TITLE 21--Food and Drugs
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 882--NEUROLOGICAL 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--NEUROLOGICAL DIAGNOSTIC DEVICES
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Nasopharyngeal electrode.
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Electroencephalograph electrode/lead tester.
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Electroencephalogram (EEG) signal spectrum analyzer.
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Electroencephalograph test signal generator.
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Galvanic skin response measurement device.
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Nerve conduction velocity measurement device.
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Skin potential measurement device.
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Powered direct-contact temperature measurement device.
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Intracranial pressure monitoring device.
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Physiological signal amplifier.
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Physiological signal conditioner.
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Electroencephalogram (EEG) telemetry system.
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Evoked response electrical stimulator.
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Evoked response mechanical stimulator.
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Evoked response photic stimulator.
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Evoked response auditory stimulator.
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Ultrasonic scanner calibration test block.
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Subparts C-D--[RESERVED]
Subpart E--NEUROLOGICAL SURGICAL DEVICES
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Clip forming/cutting instrument.
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Cryogenic surgical device.
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Dowel cutting instrument.
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Manual cranial drills, burrs, trephines, and their accessories
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Powered compound cranial drills, burrs, trephines, and their accessories.
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Powered simple cranial drills, burrs, trephines, and their accessories.
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Cranial drill handpiece (brace).
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Electric cranial drill motor.
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Pneumatic cranial drill motor.
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Radiofrequency lesion generator.
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Neurosurgical head holder (skull clamp).
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Cranioplasty material forming instrument.
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Microsurgical instrument.
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Nonpowered neurosurgical instrument.
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Shunt system implantation instrument.
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Neurosurgical suture needle.
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Radiofrequency lesion probe.
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Self-retaining retractor for neurosurgery.
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Subpart F--NEUROLOGICAL THERAPEUTIC DEVICES
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Methyl methacrylate for aneurysmorrhaphy.
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Intravascular occluding catheter.
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Implanted malleable clip.
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Aversive conditioning device.
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Methyl methacrylate for cranioplasty.
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Preformed alterable cranioplasty plate.
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Preformed nonalterable cranioplasty plate.
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Cranioplasty plate fastener.
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Lesion temperature monitor.
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Central nervous system fluid shunt and components.
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Cranial electrotheraphy stimulator.
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External functional neuromuscular stimulator.
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Implanted cerebellar stimulator.
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Implanted diaphragmatic/phrenic nerve stimulator.
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Implanted intracerebral/subcortical stimulator for pain relief.
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Implanted spinal cord stimulator for bladder evacuation.
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Implanted neuromuscular stimulator.
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Implanted peripheral nerve stimulator for pain relief.
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Implanted spinal cord stimulator for pain relief.
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Transcutaneous electrical nerve stimulator for pain relief.
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Preformed craniosynostosis strip.
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Electroconvulsive therapy device.
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Neurovascular embolization device.
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Skull tongs for traction.
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