21 CFR 882.1855 — Encephalogram Telemetry System
Neurology (NE) · Part 882 Subpart B—Neurological Diagnostic Devices · § 882.1855
Identification
An electroencephalogram (EEG) telemetry system consists of transmitters, receivers, and other components used for remotely monitoring or measuring EEG signals by means of radio or telephone transmission systems.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GYE | Encephalogram Telemetry System | 2 | 20 |
Special Controls
GYE — Encephalogram Telemetry System
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.
eCFR
