The following data is part of a premarket notification filed by Frontier Products with the FDA for Unicuf, Blood Pressure Cuff.
Device ID | K801099 |
510k Number | K801099 |
Device Name: | UNICUF, BLOOD PRESSURE CUFF |
Classification | Blood Pressure Cuff |
Applicant | FRONTIER PRODUCTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DXQ |
CFR Regulation Number | 870.1120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-05-09 |
Decision Date | 1980-05-30 |