K203378 is an FDA 510(k) clearance for the Pulsehaler. This device is classified as a Spirometer, Therapeutic (incentive) (Class II - Special Controls, product code BWF).
Submitted by Respinova, Ltd. (Herzliya, IL). The FDA issued a Cleared decision on March 31, 2021, 134 days after receiving the submission on November 17, 2020.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5690.
| 510(k) Number | K203378 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 17, 2020 |
| Decision Date | March 31, 2021 |
| Days to Decision | 134 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 |