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FDA 510(k)

A&D Medical UA-1200BLE UltraConnect Digital Blood Pressure Monitor

K-Number: K163683 · 2017-05-03

ApplicantA&D Company, Ltd.
Decision Date2017-05-03
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

A&D Medical UA-1200BLE UltraConnect Digital Blood Pressure Monitor is the device name listed in this FDA 510(k) record. The listed applicant is A&D Company, Ltd.. It received FDA 510(k) clearance on 2017-05-03 under 510(k) number K163683. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the A&D Medical UA-1200BLE UltraConnect Digital Blood Pressure Monitor?

A&D Medical UA-1200BLE UltraConnect Digital Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2017-05-03. The listed applicant is A&D Company, Ltd.. The 510(k) number is K163683.

When did A&D Medical UA-1200BLE UltraConnect Digital Blood Pressure Monitor receive FDA 510(k) clearance?

A&D Medical UA-1200BLE UltraConnect Digital Blood Pressure Monitor received FDA 510(k) clearance on 2017-05-03, under 510(k) number K163683.

Who is the listed applicant for A&D Medical UA-1200BLE UltraConnect Digital Blood Pressure Monitor?

The FDA 510(k) record lists A&D Company, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for A&D Medical UA-1200BLE UltraConnect Digital Blood Pressure Monitor?

The FDA product code for A&D Medical UA-1200BLE UltraConnect Digital Blood Pressure Monitor is DXN.

Other records listing A&D Company, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K212168A&D Medical UM-212BLE Blood Pressure MonitorK173065A&D Medical Blood Pressure MonitorsK173191A&D Medical Blood Pressure MonitorsK170196A&D Medical UB-1100BLE UltraConnect Digital Blood Pressure MonitorK151953A&D Medical TM-2657 Family of Digital Blood Pressure Monitors

Related Devices (Code: DXN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261061BP Go (BPP-855)Wellvii, Inc.K253425Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P)Joytech Healthcare Co. , Ltd.K261136Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D)Guangzhou Daxin Health Technology Co., Ltd.K261082Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)Microlife CorporationK253126Wrist Blood Pressure Monitor (XW-05)Shenzhen Ziqing Medical Equipment Co., Ltd.K260693VicorderCS (VCS-SYS-1100)80 Beats Medical GmbH

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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