The following data is part of a premarket notification filed by Trudell Medical International with the FDA for Combined Aerobika Opep And Versapap Device.
| Device ID | K183108 |
| 510k Number | K183108 |
| Device Name: | Combined Aerobika OPEP And VersaPAP Device |
| Classification | Spirometer, Therapeutic (incentive) |
| Applicant | Trudell Medical International 725 Baransway Drive London, CA N5v 5g4 |
| Contact | Marianne Tanton |
| Correspondent | Paul Dryden Trudell Medical International 725 Third Street London, CA N5v 5g4 |
| Product Code | BWF |
| CFR Regulation Number | 868.5690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-08 |
| Decision Date | 2019-08-16 |