The following data is part of a premarket notification filed by Trudell Medical Intl. with the FDA for Aerobika Positive Expiratory Pressure Device.
| Device ID | K123400 |
| 510k Number | K123400 |
| Device Name: | AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE |
| Classification | Spirometer, Therapeutic (incentive) |
| Applicant | TRUDELL MEDICAL INTL. 725 THIRD ST. London, CA N5v 5g4 |
| Contact | Darryl Fischer |
| Correspondent | Darryl Fischer TRUDELL MEDICAL INTL. 725 THIRD ST. 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 | 2012-11-05 |
| Decision Date | 2013-05-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 62860110501046 | K123400 | 000 |
| 62860110501022 | K123400 | 000 |
| 00762860105010 | K123400 | 000 |
| 50604351505129 | K123400 | 000 |