K150044 is an FDA 510(k) clearance for the O-PEP. This device is classified as a Spirometer, Therapeutic (incentive) (Class II - Special Controls, product code BWF).
Submitted by Pari Respiratory Equipment, Inc. (Midlothian, US). The FDA issued a Cleared decision on May 27, 2016, 501 days after receiving the submission on January 12, 2015.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5690.
| 510(k) Number | K150044 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 12, 2015 |
| Decision Date | May 27, 2016 |
| Days to Decision | 501 days |
| Submission Type | Traditional |
| 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 |