The following data is part of a premarket notification filed by Telediagnostic Systems, Inc. with the FDA for Rs-10 Telephonic Polysomnography Receiver.
| Device ID | K885328 |
| 510k Number | K885328 |
| Device Name: | RS-10 TELEPHONIC POLYSOMNOGRAPHY RECEIVER |
| Classification | Encephalogram Telemetry System |
| Applicant | TELEDIAGNOSTIC SYSTEMS, INC. 2053 SUTTER ST. San Francisco, CA 94115 |
| Contact | Larry Woodard |
| Correspondent | Larry Woodard TELEDIAGNOSTIC SYSTEMS, INC. 2053 SUTTER ST. San Francisco, CA 94115 |
| Product Code | GYE |
| CFR Regulation Number | 882.1855 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-28 |
| Decision Date | 1989-03-22 |