K802426 is an FDA 510(k) clearance for the RESPO2 OXYGEN CONCENTRATOR. This device is classified as a Generator, Oxygen, Portable (Class II - Special Controls, product code CAW).
Submitted by Mada Medical Products, Inc. (Walker, US). The FDA issued a Cleared decision on October 23, 1980, 17 days after receiving the submission on October 6, 1980.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5440.
| 510(k) Number | K802426 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 06, 1980 |
| Decision Date | October 23, 1980 |
| Days to Decision | 17 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 |