The following data is part of a premarket notification filed by Telediagnostic Systems, Inc. with the FDA for Vista Polysomnography Computer System.
| Device ID | K904328 |
| 510k Number | K904328 |
| Device Name: | VISTA POLYSOMNOGRAPHY COMPUTER SYSTEM |
| Classification | Conditioner, Signal, Physiological |
| 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 | GWK |
| CFR Regulation Number | 882.1845 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-20 |
| Decision Date | 1991-06-18 |