The following data is part of a premarket notification filed by Kinetix with the FDA for Respirometer.
| Device ID | K832401 |
| 510k Number | K832401 |
| Device Name: | RESPIROMETER |
| Classification | Spirometer, Diagnostic |
| Applicant | KINETIX 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-07-20 |
| Decision Date | 1984-04-30 |