The following data is part of a premarket notification filed by Telediagnostic Systems, Inc. with the FDA for S-10 Telephonic Polysomnograph.
| Device ID | K874257 |
| 510k Number | K874257 |
| Device Name: | S-10 TELEPHONIC POLYSOMNOGRAPH |
| 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 | 1987-10-20 |
| Decision Date | 1987-12-11 |