M10 EEG MONITOR SCOPE
Device Facts
| Record ID | K871120 |
|---|---|
| Device Name | M10 EEG MONITOR SCOPE |
| Applicant | Telediagnostic Systems, Inc. |
| Product Code | GYE · Neurology |
| Decision Date | May 1, 1987 |
| 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.
