K051540 is an FDA 510(k) clearance for the INOVO, INC. INDEPENDENCE OXYGEN CONSERVING REGULATOR. This device is classified as a Conserver, Oxygen (Class II - Special Controls, product code NFB).
Submitted by Inovo, Inc. (Naples, US). The FDA issued a Cleared decision on September 21, 2005, 103 days after receiving the submission on June 10, 2005.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5905.
| 510(k) Number | K051540 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 10, 2005 |
| Decision Date | September 21, 2005 |
| Days to Decision | 103 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | NFB — Conserver, Oxygen |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5905 |