The following data is part of a premarket notification filed by A & D Engineering, Inc. with the FDA for A & D Medical Lifesource Ua-781, Ua781pc, & Ua-781t Digital Blood Pressure Monitors.
Device ID | K012472 |
510k Number | K012472 |
Device Name: | A & D MEDICAL LIFESOURCE UA-781, UA781PC, & UA-781T DIGITAL BLOOD PRESSURE MONITORS |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | A & D ENGINEERING, INC. 1555 MC CANDLESS DR. Milpitas, CA 95035 |
Contact | Jerry Wang |
Correspondent | Jerry Wang A & D ENGINEERING, INC. 1555 MC CANDLESS DR. Milpitas, CA 95035 |
Product Code | DXN |
CFR Regulation Number | 870.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-08-02 |
Decision Date | 2002-02-15 |