The following data is part of a premarket notification filed by Dhd Medical Products Div. Diemolding Corp. with the FDA for Inspiratory Resistor Kit.
| Device ID | K831142 |
| 510k Number | K831142 |
| Device Name: | INSPIRATORY RESISTOR KIT |
| Classification | Spirometer, Therapeutic (incentive) |
| Applicant | DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | BWF |
| CFR Regulation Number | 868.5690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-04-07 |
| Decision Date | 1983-06-03 |