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FDA 510(k)

Digital Blood Pressure Monitor

K-Number: K153033 · 2016-06-24

ApplicantSuzhou Sunspiri Co., Ltd.
Decision Date2016-06-24
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Digital Blood Pressure Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Sunspiri Co., Ltd.. It received FDA 510(k) clearance on 2016-06-24 under 510(k) number K153033. 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 Digital Blood Pressure Monitor?

Digital Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2016-06-24. The listed applicant is Suzhou Sunspiri Co., Ltd.. The 510(k) number is K153033.

When did Digital Blood Pressure Monitor receive FDA 510(k) clearance?

Digital Blood Pressure Monitor received FDA 510(k) clearance on 2016-06-24, under 510(k) number K153033.

Who is the listed applicant for Digital Blood Pressure Monitor?

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

What is the FDA product code for Digital Blood Pressure Monitor?

The FDA product code for Digital Blood Pressure Monitor is DXN.

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

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

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