K031983 is an FDA 510(k) clearance for the INOVO, INC, ECONOMIZER CONSERVING REGULATOR. This device is classified as a Conserver, Oxygen (Class II - Special Controls, product code NFB).
Submitted by Inovo, Inc. (Great Neck, US). The FDA issued a Cleared decision on September 15, 2003, 81 days after receiving the submission on June 26, 2003.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5905.
| 510(k) Number | K031983 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 26, 2003 |
| Decision Date | September 15, 2003 |
| Days to Decision | 81 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 |