FDA 510(k)

Arm-Type Fully Automatic Digital Blood Pressure Monitor

K-Number: K161577 · 2017-02-08

ApplicantSejoy Electronics & Instruments Co., Ltd.

Decision Date2017-02-08

Product CodeDXN

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Arm-Type Fully Automatic Digital Blood Pressure Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Sejoy Electronics & Instruments Co., Ltd.. It received FDA 510(k) clearance on 2017-02-08 under 510(k) number K161577. 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 Fully Automatic Digital Blood Pressure Monitor?

Arm-Type Fully Automatic Digital Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2017-02-08. The listed applicant is Sejoy Electronics & Instruments Co., Ltd.. The 510(k) number is K161577.

When did Arm-Type Fully Automatic Digital Blood Pressure Monitor receive FDA 510(k) clearance?

Arm-Type Fully Automatic Digital Blood Pressure Monitor received FDA 510(k) clearance on 2017-02-08, under 510(k) number K161577.

Who is the listed applicant for Arm-Type Fully Automatic Digital Blood Pressure Monitor?

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

What is the FDA product code for Arm-Type Fully Automatic Digital Blood Pressure Monitor?

The FDA product code for Arm-Type Fully Automatic Digital Blood Pressure Monitor is DXN.

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Other records listing Sejoy Electronics & Instruments 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.