The following data is part of a premarket notification filed by Ohio Medical Products with the FDA for Cnibp Blood Pressure Measurement Sys.
Device ID | K822055 |
510k Number | K822055 |
Device Name: | CNIBP BLOOD PRESSURE MEASUREMENT SYS |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | OHIO MEDICAL PRODUCTS 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | DXN |
CFR Regulation Number | 870.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-07-13 |
Decision Date | 1982-11-01 |