21 C.F.R. § 882.4560   Stereotaxic instrument.


Title 21 - Food and Drugs


Title 21: Food and Drugs
PART 882—NEUROLOGICAL DEVICES
Subpart E—Neurological Surgical Devices

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§ 882.4560   Stereotaxic instrument.

(a) Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

(b) Classification. Class II (performance standards).

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