K790057 is an FDA 510(k) clearance for the CATHETER, OXYGEN. This device is classified as a Catheter, Nasal, Oxygen (Class I - General Controls, product code BZB).
Submitted by Medline Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 5, 1979, 27 days after receiving the submission on January 9, 1979.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5350.
| 510(k) Number | K790057 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 09, 1979 |
| Decision Date | February 05, 1979 |
| Days to Decision | 27 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | BZB — Catheter, Nasal, Oxygen |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.5350 |