The following data is part of a premarket notification filed by Trudell Medical Intl. with the FDA for Aeropep.
| Device ID | K012368 |
| 510k Number | K012368 |
| Device Name: | AEROPEP |
| Classification | Spirometer, Therapeutic (incentive) |
| Applicant | TRUDELL MEDICAL INTL. 725 THIRD ST. London, Ontario, CA N5v 5g4 |
| Contact | Tom Holbrook |
| Correspondent | Tom Holbrook TRUDELL MEDICAL INTL. 725 THIRD ST. London, Ontario, 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 | 2001-07-26 |
| Decision Date | 2002-02-12 |