K974417 is an FDA 510(k) clearance for the SULLIVAN VPAP II ST-A NASAL VPAP SYSTEM. This device is classified as a Ventilator, Continuous, Non-life-supporting (Class II - Special Controls, product code MNS).
Submitted by ResMed Corp (San Diego, US). The FDA issued a Cleared decision on June 24, 1998, 212 days after receiving the submission on November 24, 1997.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5895.
| 510(k) Number | K974417 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 24, 1997 |
| Decision Date | June 24, 1998 |
| Days to Decision | 212 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | MNS — Ventilator, Continuous, Non-life-supporting |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5895 |