The following data is part of a premarket notification filed by Respinova Ltd. with the FDA for Pulsehaler.
| Device ID | K203378 |
| 510k Number | K203378 |
| Device Name: | Pulsehaler |
| Classification | Spirometer, Therapeutic (incentive) |
| Applicant | Respinova Ltd. Hachoshlim 8 Herzliya, IL 4672408 |
| Contact | Cliff Ansel |
| Correspondent | Joel Ironstone Ironstone Product Development Inc. 250 Carlaw Avenue Suite 108 Toronto, CA M4m 3l1 |
| Product Code | BWF |
| CFR Regulation Number | 868.5690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-17 |
| Decision Date | 2021-03-31 |