The following data is part of a premarket notification filed by A & D Engineering, Inc. with the FDA for A&d Medical Ua-851thw Digital Blood Pressure Monitor.
| Device ID | K082734 |
| 510k Number | K082734 |
| Device Name: | A&D MEDICAL UA-851THW DIGITAL BLOOD PRESSURE MONITOR |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | A & D ENGINEERING, INC. 1756 AUTOMATION PARKWAY San Jose, CA 95131 |
| Contact | Jerry Wang |
| Correspondent | Jerry Wang A & D ENGINEERING, INC. 1756 AUTOMATION PARKWAY San Jose, CA 95131 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-18 |
| Decision Date | 2008-11-13 |
| Summary: | summary |