K844963 is an FDA 510(k) clearance for the VITAPEP. This device is classified as a Spirometer, Therapeutic (incentive) (Class II - Special Controls, product code BWF).
Submitted by Vitalograph , Ltd. (Lenexa, US). The FDA issued a Cleared decision on June 7, 1985, 165 days after receiving the submission on December 24, 1984.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5690.
| 510(k) Number | K844963 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 24, 1984 |
| Decision Date | June 07, 1985 |
| Days to Decision | 165 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | - |
| Product Code | BWF - Spirometer, Therapeutic (incentive) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5690 |