The following data is part of a premarket notification filed by A & D Engineering, Inc. with the FDA for A&d Medical Ua-767pc Digital Blood Pressure Monitor.
Device ID | K982481 |
510k Number | K982481 |
Device Name: | A&D MEDICAL UA-767PC DIGITAL BLOOD PRESSURE MONITOR |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | A & D ENGINEERING, INC. 1555 MC CANDLESS DR. Milpitas, CA 95035 |
Contact | Jerry Wang |
Product Code | DXN |
CFR Regulation Number | 870.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 1998-07-16 |
Decision Date | 1998-09-25 |