FDA 510(k)

Automatic Upper Arm Blood Pressure Monitor

K-Number: K193624 · 2020-07-10

ApplicantDongguan E-Test Technology Co., Ltd.

Decision Date2020-07-10

Product CodeDXN

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Automatic Upper Arm Blood Pressure Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Dongguan E-Test Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-07-10 under 510(k) number K193624. 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 Automatic Upper Arm Blood Pressure Monitor?

Automatic Upper Arm Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2020-07-10. The listed applicant is Dongguan E-Test Technology Co., Ltd.. The 510(k) number is K193624.

When did Automatic Upper Arm Blood Pressure Monitor receive FDA 510(k) clearance?

Automatic Upper Arm Blood Pressure Monitor received FDA 510(k) clearance on 2020-07-10, under 510(k) number K193624.

Who is the listed applicant for Automatic Upper Arm Blood Pressure Monitor?

The FDA 510(k) record lists Dongguan E-Test Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Automatic Upper Arm Blood Pressure Monitor?

The FDA product code for Automatic Upper Arm Blood Pressure Monitor is DXN.

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Other records listing Dongguan E-Test Technology Co., Ltd. as applicant

K250231Automatic Upper Arm Blood Pressure Monitor (BA-831X, BA-832X, BA-833X, BA-837X, BA-838X, BA-842X, BA-843X, BA-845X, BA-847X, BA-849X, BA-851X, BA-852X, BA-855X, BA-835, BA-836, BA-839, BA-840, BA-856)K193621Digital Thermometer-(Model BT-301, BT-302, BT-303, BT-305, BT-306, BT-308, BT-311, BT-318)K193628AGE Automatic Wrist Blood Pressure Monitor K193627Automatic Upper Arm Blood Pressure Monitor

Related Devices (Code: DXN)

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 Corporation K253126Wrist Blood Pressure Monitor (XW-05)Shenzhen Ziqing Medical Equipment Co., Ltd.K260693VicorderCS (VCS-SYS-1100)80 Beats Medical GmbH

Official Source

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