K904328 is an FDA 510(k) clearance for the VISTA POLYSOMNOGRAPHY COMPUTER SYSTEM. This device is classified as a Conditioner, Signal, Physiological (Class II - Special Controls, product code GWK).
Submitted by Telediagnostic Systems, Inc. (San Francisco, US). The FDA issued a Cleared decision on June 18, 1991, 271 days after receiving the submission on September 20, 1990.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1845.
| 510(k) Number | K904328 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 20, 1990 |
| Decision Date | June 18, 1991 |
| Days to Decision | 271 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | — |
| Product Code | GWK — Conditioner, Signal, Physiological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1845 |