A&D MEDICAL UA-651 DIGITAL BLOOD PRESSURE MONITOR

System, Measurement, Blood-pressure, Non-invasive

A & D CO., LTD.

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.

Pre-market Notification Details

Device IDK141160
510k NumberK141160
Device Name:A&D MEDICAL UA-651 DIGITAL BLOOD PRESSURE MONITOR
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant A & D CO., LTD. 1756 AUTOMATION PARKWAY San Jose,  CA  95131
ContactJerry Wang
CorrespondentJerry Wang
A & D CO., LTD. 1756 AUTOMATION PARKWAY San Jose,  CA  95131
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-05-05
Decision Date2014-10-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00093764603785 K141160 000
00093764603341 K141160 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.