The following data is part of a premarket notification filed by A & D Co., Ltd. with the FDA for A&d Medical Ua-651 Digital Blood Pressure Monitor.
Device ID | K141160 |
510k Number | K141160 |
Device Name: | A&D MEDICAL UA-651 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 | 2014-05-05 |
Decision Date | 2014-10-07 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00093764603785 | K141160 | 000 |
00093764603341 | K141160 | 000 |
00093764604492 | K141160 | 000 |