FDA 510(k)

Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm Style

K-Number: K181104 · 2018-08-29

ApplicantShenzhen Combei Technology Co., Ltd.

Decision Date2018-08-29

Product CodeDXN

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm Style is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Combei Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-08-29 under 510(k) number K181104. 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 Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm Style?

Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm Style is a medical device that received FDA 510(k) clearance on 2018-08-29. The listed applicant is Shenzhen Combei Technology Co., Ltd.. The 510(k) number is K181104.

When did Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm Style receive FDA 510(k) clearance?

Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm Style received FDA 510(k) clearance on 2018-08-29, under 510(k) number K181104.

Who is the listed applicant for Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm Style?

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

What is the FDA product code for Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm Style?

The FDA product code for Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm Style is DXN.

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Other records listing Shenzhen Combei Technology Co., Ltd. as applicant

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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.