K983631 is an FDA 510(k) clearance for the AUTO-PEEP MEASUREMENT DEVICE, MODEL # KC 9-P. This device is classified as a Valve, Non-rebreathing (Class II - Special Controls, product code CBP).
Submitted by Instrumentation Industries, Inc. (Bethel Park, US). The FDA issued a Cleared decision on July 1, 1999, 259 days after receiving the submission on October 15, 1998.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5870.
| 510(k) Number | K983631 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 15, 1998 |
| Decision Date | July 01, 1999 |
| Days to Decision | 259 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | CBP — Valve, Non-rebreathing |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5870 |