The following data is part of a premarket notification filed by Ohio Medical Products with the FDA for Diffusion Option, Omni-lab.
| Device ID | K781871 |
| 510k Number | K781871 |
| Device Name: | DIFFUSION OPTION, OMNI-LAB |
| Classification | Analyzer, Gas, Carbon-monoxide, Gaseous-phase |
| Applicant | OHIO MEDICAL PRODUCTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CCJ |
| CFR Regulation Number | 868.1430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-11-03 |
| Decision Date | 1979-01-02 |