The following data is part of a premarket notification filed by A&d Company, Ltd. with the FDA for A&d Medical Ub-1100ble Ultraconnect Digital Blood Pressure Monitor.
Device ID | K170196 |
510k Number | K170196 |
Device Name: | A&D Medical UB-1100BLE 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 | 2017-01-23 |
Decision Date | 2017-05-17 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00093764603709 | K170196 | 000 |