K853004 is an FDA 510(k) clearance for the PORTABLE OXYGEN UNIT. This device is classified as a Generator, Oxygen, Portable (Class II - Special Controls, product code CAW).
Submitted by B & F Medical Products, Inc. (Toledo, US). The FDA issued a Cleared decision on August 29, 1985, 44 days after receiving the submission on July 16, 1985.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5440.
| 510(k) Number | K853004 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 16, 1985 |
| Decision Date | August 29, 1985 |
| Days to Decision | 44 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | CAW — Generator, Oxygen, Portable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5440 |