The following data is part of a premarket notification filed by Promedical Industries, Inc. with the FDA for Digital Sphygmomanometer Ua-273.
Device ID | K841381 |
510k Number | K841381 |
Device Name: | DIGITAL SPHYGMOMANOMETER UA-273 |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | PROMEDICAL INDUSTRIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DXN |
CFR Regulation Number | 870.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-04-02 |
Decision Date | 1984-06-14 |