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FDA 510(k)

Arm-type Electronic Blood Pressure Monitor

K-Number: K183058 · 2019-07-03

ApplicantShenzhen Bsx Technology Electronics Co., Ltd.
Decision Date2019-07-03
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Arm-type Electronic Blood Pressure Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Bsx Technology Electronics Co., Ltd.. It received FDA 510(k) clearance on 2019-07-03 under 510(k) number K183058. 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 Arm-type Electronic Blood Pressure Monitor?

Arm-type Electronic Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2019-07-03. The listed applicant is Shenzhen Bsx Technology Electronics Co., Ltd.. The 510(k) number is K183058.

When did Arm-type Electronic Blood Pressure Monitor receive FDA 510(k) clearance?

Arm-type Electronic Blood Pressure Monitor received FDA 510(k) clearance on 2019-07-03, under 510(k) number K183058.

Who is the listed applicant for Arm-type Electronic Blood Pressure Monitor?

The FDA 510(k) record lists Shenzhen Bsx Technology Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Arm-type Electronic Blood Pressure Monitor?

The FDA product code for Arm-type Electronic Blood Pressure Monitor is DXN.

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Related Devices (Code: DXN)

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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

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