K933583 is an FDA 510(k) clearance for the NONREBREATHING VALVE. This device is classified as a Mask, Oxygen, Non-rebreathing (Class I - General Controls, product code KGB).
Submitted by Hans Rudolph, Inc. (Kansas City, US). The FDA issued a Cleared decision on January 3, 1994, 164 days after receiving the submission on July 23, 1993.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5570.
| 510(k) Number | K933583 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 23, 1993 |
| Decision Date | January 03, 1994 |
| Days to Decision | 164 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | KGB — Mask, Oxygen, Non-rebreathing |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.5570 |