K861325 is an FDA 510(k) clearance for the MAXI-USE O2 DEVICE. This device is classified as a Conserver, Oxygen (Class II - Special Controls, product code NFB).
Submitted by B & F Medical Products, Inc. (Toledo, US). The FDA issued a Cleared decision on September 9, 1986, 153 days after receiving the submission on April 9, 1986.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5905.
| 510(k) Number | K861325 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 09, 1986 |
| Decision Date | September 09, 1986 |
| Days to Decision | 153 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | NFB — Conserver, Oxygen |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5905 |