The following data is part of a premarket notification filed by Dhd Diemolding Healthcare Div. with the FDA for Expiratory Breathing Exerciser.
| Device ID | K945118 |
| 510k Number | K945118 |
| Device Name: | EXPIRATORY BREATHING EXERCISER |
| Classification | Spirometer, Therapeutic (incentive) |
| Applicant | DHD DIEMOLDING HEALTHCARE DIV. ONE MADISON ST. Wampsville, NY 13163 |
| Contact | Jean Wallace |
| Correspondent | Jean Wallace DHD DIEMOLDING HEALTHCARE DIV. ONE MADISON ST. Wampsville, NY 13163 |
| Product Code | BWF |
| CFR Regulation Number | 868.5690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-18 |
| Decision Date | 1995-01-13 |