GroundRules
21 CFR 882.1835: Physiological signal amplifier.
Where this section sits in the code
- 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 B—Neurological Diagnostic Devices
(a) Identification. A physiological signal amplifier is a general purpose device used to electrically amplify signals derived from various physiological sources (e.g., the electroencephalogram).
(b) Classification. Class II (performance standards).
Collected 2026-08-27T02:24:47Z. Source file · JSON