The following data is part of a premarket notification filed by A&d Company, Ltd with the FDA for A&d Medical Ua-1200ble Ultraconnect Digital Blood Pressure Monitor.
| Device ID | K163683 |
| 510k Number | K163683 |
| Device Name: | A&D Medical UA-1200BLE UltraConnect Digital Blood Pressure Monitor |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | A&D COMPANY, LTD 1756 AUTOMATION PARKWAY San Jose, CA 95131 |
| Contact | Jerry Wang |
| Correspondent | Jerry Wang A&D COMPANY, LTD 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 | 2016-12-28 |
| Decision Date | 2017-05-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00681131247887 | K163683 | 000 |