K943402 is an FDA 510(k) clearance for the K.P.R. (KING PERSONAL RESUSCITATOR). This device is classified as a Valve, Non-rebreathing (Class II - Special Controls, product code CBP).
Submitted by King Systems Corp. (Noblesville, US). The FDA issued a Cleared decision on August 19, 1994, 36 days after receiving the submission on July 14, 1994.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5870.
| 510(k) Number | K943402 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 14, 1994 |
| Decision Date | August 19, 1994 |
| Days to Decision | 36 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CBP — Valve, Non-rebreathing |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5870 |