The following data is part of a premarket notification filed by A & D Engineering, Inc. with the FDA for A & D Ub-302 Wrist Digital Blood Pressure Monitor.
| Device ID | K960319 |
| 510k Number | K960319 |
| Device Name: | A & D UB-302 WRIST 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 |
| 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 | 1996-01-23 |
| Decision Date | 1996-07-02 |