K904222 is an FDA 510(k) clearance for the VISTA GRAPH POLYSOMNOGRAPHY AMPLIFIER. This device is classified as a Amplifier, Physiological Signal (Class II - Special Controls, product code GWL).
Submitted by Telediagnostic Systems, Inc. (San Francisco, US). The FDA issued a Cleared decision on January 18, 1991, 127 days after receiving the submission on September 13, 1990.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1835.
| 510(k) Number | K904222 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 13, 1990 |
| Decision Date | January 18, 1991 |
| Days to Decision | 127 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | — |
| Product Code | GWL — Amplifier, Physiological Signal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1835 |