The following data is part of a premarket notification filed by Trudell Medical International with the FDA for Aerobika Opep Devive With Manometer.
| Device ID | K150173 |
| 510k Number | K150173 |
| Device Name: | Aerobika OPEP Devive With Manometer |
| Classification | Spirometer, Therapeutic (incentive) |
| Applicant | Trudell Medical International 725 Third Street London,ontario, CA N5v 5g4 |
| Contact | Darryl Fischer |
| Correspondent | Darryl Fischer Trudell Medical International 725 Third Street London,ontario, CA N5v 5g4 |
| Product Code | BWF |
| CFR Regulation Number | 868.5690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-26 |
| Decision Date | 2015-10-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 62860110504023 | K150173 | 000 |
| 62860110502029 | K150173 | 000 |
| 10762860105048 | K150173 | 000 |
| 10762860105024 | K150173 | 000 |