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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