K905404 is an FDA 510(k) clearance for the MEDTRONIC SULLIVAN NASAL CPAP SYSTEM. This device is classified as a Ventilator, Non-continuous (respirator) (Class II - Special Controls, product code BZD).
Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on May 13, 1991, 161 days after receiving the submission on December 3, 1990.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5905.
| 510(k) Number | K905404 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 03, 1990 |
| Decision Date | May 13, 1991 |
| Days to Decision | 161 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | BZD — Ventilator, Non-continuous (respirator) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5905 |