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Home Page > Executive Branch > Code of Federal Regulations > Electronic Code of Federal Regulations
e-CFR Data is current as of February 4, 2010
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 electrotherapy 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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