The following data is part of a premarket notification filed by A & D Co., Ltd. with the FDA for A&d Medical Ub-543 Digital Blood Pressure Monitor.
| Device ID | K141179 |
| 510k Number | K141179 |
| Device Name: | A&D MEDICAL UB-543 DIGITAL BLOOD PRESSURE MONITOR |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | A & D CO., LTD. 1756 AUTOMATION PARKWAY San Jose, CA 95131 |
| Contact | Jerry Wang |
| Correspondent | Jerry Wang A & D CO., 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 | 2014-05-07 |
| Decision Date | 2014-06-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00093764603358 | K141179 | 000 |
| 00075450227406 | K141179 | 000 |
| 00860418002672 | K141179 | 000 |
| 00036800456617 | K141179 | 000 |