The following data is part of a premarket notification filed by Pn Medical with the FDA for The Breather Inspiratory/expiratory Muscle Trainer.
| Device ID | K972824 |
| 510k Number | K972824 |
| Device Name: | THE BREATHER INSPIRATORY/EXPIRATORY MUSCLE TRAINER |
| Classification | Spirometer, Therapeutic (incentive) |
| Applicant | PN MEDICAL 214 NORTH GOLDENROD RD., #6 Orlando, FL 32807 |
| Contact | Peggy Nicholson |
| Correspondent | Peggy Nicholson PN MEDICAL 214 NORTH GOLDENROD RD., #6 Orlando, FL 32807 |
| Product Code | BWF |
| CFR Regulation Number | 868.5690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-30 |
| Decision Date | 1998-04-03 |