The following data is part of a premarket notification filed by A & D Engineering, Inc. with the FDA for A&d Medical Ua-789 Digital Blood Pressure Monitor.
| Device ID | K062027 |
| 510k Number | K062027 |
| Device Name: | A&D MEDICAL UA-789 DIGITAL BLOOD PRESSURE MONITOR |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | A & D ENGINEERING, INC. 1555 MCCANDLESS DR. Milpitas, CA 95035 |
| Contact | Jerry Wang |
| Correspondent | Jerry Wang A & D ENGINEERING, INC. 1555 MCCANDLESS DR. Milpitas, CA 95035 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-18 |
| Decision Date | 2007-01-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00093764600623 | K062027 | 000 |