The following data is part of a premarket notification filed by Kinetix with the FDA for Inspirometer.
| Device ID | K833012 |
| 510k Number | K833012 |
| Device Name: | INSPIROMETER |
| Classification | Spirometer, Therapeutic (incentive) |
| Applicant | KINETIX 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 | 1983-09-06 |
| Decision Date | 1983-11-08 |