K222018 is an FDA 510(k) clearance for the Breathe+. This device is classified as a Spirometer, Therapeutic (incentive) (Class II - Special Controls, product code BWF).
Submitted by Peep Medical, LLC Dba Go2 Devices (Houston, US). The FDA issued a Cleared decision on June 2, 2023, 329 days after receiving the submission on July 8, 2022.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5690.
| 510(k) Number | K222018 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 08, 2022 |
| Decision Date | June 02, 2023 |
| Days to Decision | 329 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 |