K150173 is an FDA 510(k) clearance for the Aerobika OPEP Devive with Manometer. This device is classified as a Spirometer, Therapeutic (incentive) (Class II - Special Controls, product code BWF).
Submitted by Trudell Medical International (London, CA). The FDA issued a Cleared decision on October 15, 2015, 262 days after receiving the submission on January 26, 2015.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5690.
| 510(k) Number | K150173 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 26, 2015 |
| Decision Date | October 15, 2015 |
| Days to Decision | 262 days |
| Submission Type | Special |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BWF — Spirometer, Therapeutic (incentive) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5690 |