K953055 is an FDA 510(k) clearance for the MISTASSIST BREATHING EXERCISER. This device is classified as a Spirometer, Therapeutic (incentive) (Class II - Special Controls, product code BWF).
Submitted by The Merlin Corp. (Camarillo, US). The FDA issued a Cleared decision on February 8, 1996, 223 days after receiving the submission on June 30, 1995.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5690.
| 510(k) Number | K953055 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 30, 1995 |
| Decision Date | February 08, 1996 |
| Days to Decision | 223 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | BWF — Spirometer, Therapeutic (incentive) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5690 |