The following data is part of a premarket notification filed by Ohio Medical Products with the FDA for Analyzer, Sentorr Blood Gas.
Device ID | K760088 |
510k Number | K760088 |
Device Name: | ANALYZER, SENTORR BLOOD GAS |
Classification | Analyzer, Gas, Carbon-dioxide, Partial Pressure, Blood-phase, Indwelling |
Applicant | OHIO MEDICAL PRODUCTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CCC |
CFR Regulation Number | 868.1150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-06-21 |
Decision Date | 1976-08-06 |