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FDA 510(k)

Digital Automatic Blood Pressure Monitor BPM41 Series, Digital Automatic Blood Pressure Monitor BPM45 Series

K-Number: K163648 · 2017-07-07

ApplicantGrandway Technology (Shenzhen) Limited
Decision Date2017-07-07
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Digital Automatic Blood Pressure Monitor BPM41 Series, Digital Automatic Blood Pressure Monitor BPM45 Series is the device name listed in this FDA 510(k) record. The listed applicant is Grandway Technology (Shenzhen) Limited. It received FDA 510(k) clearance on 2017-07-07 under 510(k) number K163648. 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 Automatic Blood Pressure Monitor BPM41 Series, Digital Automatic Blood Pressure Monitor BPM45 Series?

Digital Automatic Blood Pressure Monitor BPM41 Series, Digital Automatic Blood Pressure Monitor BPM45 Series is a medical device that received FDA 510(k) clearance on 2017-07-07. The listed applicant is Grandway Technology (Shenzhen) Limited. The 510(k) number is K163648.

When did Digital Automatic Blood Pressure Monitor BPM41 Series, Digital Automatic Blood Pressure Monitor BPM45 Series receive FDA 510(k) clearance?

Digital Automatic Blood Pressure Monitor BPM41 Series, Digital Automatic Blood Pressure Monitor BPM45 Series received FDA 510(k) clearance on 2017-07-07, under 510(k) number K163648.

Who is the listed applicant for Digital Automatic Blood Pressure Monitor BPM41 Series, Digital Automatic Blood Pressure Monitor BPM45 Series?

The FDA 510(k) record lists Grandway Technology (Shenzhen) Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Digital Automatic Blood Pressure Monitor BPM41 Series, Digital Automatic Blood Pressure Monitor BPM45 Series?

The FDA product code for Digital Automatic Blood Pressure Monitor BPM41 Series, Digital Automatic Blood Pressure Monitor BPM45 Series is DXN.

Related Clinical Trials

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.

NCT06508619Blood Pressure Treatment by the Corsano CardioWatch 287-2 Evaluation StudyCOMPLETEDNCT07704034Wearable-Triggered Digital Safety Net for Real-Time Monitoring & Intervention in Leptomeningeal MetastasisNOT_YET_RECRUITING

Other records listing Grandway Technology (Shenzhen) Limited as applicant

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.

K191593Digital Automatic Blood Pressure Monitor MD36 SeriesK171379Digital Automatic Wrist Blood Pressure Monitor MD4300K163679Digital Automatic Blood Pressure Monitor MD3600K163113Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series

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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