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FDA 510(k)

HRVWatch-Mini Wrist Monitor

K-Number: K201914 · 2021-06-07

ApplicantTaiwan Scientific Corporation
Decision Date2021-06-07
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HRVWatch-Mini Wrist Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Taiwan Scientific Corporation. It received FDA 510(k) clearance on 2021-06-07 under 510(k) number K201914. 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 HRVWatch-Mini Wrist Monitor?

HRVWatch-Mini Wrist Monitor is a medical device that received FDA 510(k) clearance on 2021-06-07. The listed applicant is Taiwan Scientific Corporation. The 510(k) number is K201914.

When did HRVWatch-Mini Wrist Monitor receive FDA 510(k) clearance?

HRVWatch-Mini Wrist Monitor received FDA 510(k) clearance on 2021-06-07, under 510(k) number K201914.

Who is the listed applicant for HRVWatch-Mini Wrist Monitor?

The FDA 510(k) record lists Taiwan Scientific Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HRVWatch-Mini Wrist Monitor?

The FDA product code for HRVWatch-Mini Wrist 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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