The following data is part of a premarket notification filed by Airphysio Pty Ltd with the FDA for Airphysio Positive Expiratory (pep) Device.
| Device ID | K203209 |
| 510k Number | K203209 |
| Device Name: | AirPhysio Positive Expiratory (PEP) Device |
| Classification | Spirometer, Therapeutic (incentive) |
| Applicant | AirPhysio Pty Ltd Unit 1, 43 Greenway Drive Tweed Heads South, AU Nsw 2486 |
| Contact | Paul O’brien |
| Correspondent | Rafael Aguila Accelerated Device Approval Services 6800 S.W. 40th Street, Ste. 403 Ludlum, FL 33155 |
| Product Code | BWF |
| CFR Regulation Number | 868.5690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2020-10-30 |
| Decision Date | 2021-01-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B99893699980215050 | K203209 | 000 |