K885328 is an FDA 510(k) clearance for the RS-10 TELEPHONIC POLYSOMNOGRAPHY RECEIVER. This device is classified as a Encephalogram Telemetry System (Class II - Special Controls, product code GYE).
Submitted by Telediagnostic Systems, Inc. (San Francisco, US). The FDA issued a Cleared decision on March 22, 1989, 84 days after receiving the submission on December 28, 1988.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1855.
| 510(k) Number | K885328 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 28, 1988 |
| Decision Date | March 22, 1989 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | — |
| Product Code | GYE — Encephalogram Telemetry System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1855 |