The following data is part of a premarket notification filed by Ohio Medical Products with the FDA for Ohio Cal-chek.
| Device ID | K810290 |
| 510k Number | K810290 |
| Device Name: | OHIO CAL-CHEK |
| Classification | Calibrator, Volume, Gas |
| Applicant | OHIO MEDICAL PRODUCTS 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | BXW |
| CFR Regulation Number | 868.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-02-03 |
| Decision Date | 1981-02-12 |