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 |