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e-CFR data is current as of February 23, 2021 |
Title 21 → Chapter I → Subchapter H → Part 882 → Subpart B → §882.1620 |
Title 21: Food and Drugs
PART 882—NEUROLOGICAL DEVICES
Subpart B—Neurological Diagnostic Devices
§882.1620 Intracranial pressure monitoring device.
(a) Identification. An intracranial pressure monitoring device is a device used for short-term monitoring and recording of intracranial pressures and pressure trends. The device includes the transducer, monitor, and interconnecting hardware.
(b) Classification. Class II (performance standards).