TELEMETRY SYSTEM XMT-1 & REC-1
Device Facts
| Record ID | K792371 |
|---|---|
| Device Name | TELEMETRY SYSTEM XMT-1 & REC-1 |
| Applicant | Burdick Corp. |
| Product Code | GYE · Neurology |
| Decision Date | Jan 31, 1980 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.1855 |
| Device Class | Class 2 |
Regulatory Classification
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.
Special Controls
*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.
