e-CFR data is current as of March 4, 2021 |
Title 21 → Chapter I → Subchapter H → Part 882 → Subpart E → §882.4560 |
Title 21: Food and Drugs
PART 882—NEUROLOGICAL DEVICES
Subpart E—Neurological Surgical Devices
(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).