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FDA 510(k)

Wrist-type Fully Automatic Digital Blood Pressure Monitor

K-Number: K213189 · 2022-03-01

ApplicantJoytech Healthcare Co. , Ltd.
Decision Date2022-03-01
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Wrist-type Fully Automatic Digital Blood Pressure Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Joytech Healthcare Co. , Ltd.. It received FDA 510(k) clearance on 2022-03-01 under 510(k) number K213189. 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 Wrist-type Fully Automatic Digital Blood Pressure Monitor?

Wrist-type Fully Automatic Digital Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2022-03-01. The listed applicant is Joytech Healthcare Co. , Ltd.. The 510(k) number is K213189.

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

Wrist-type Fully Automatic Digital Blood Pressure Monitor received FDA 510(k) clearance on 2022-03-01, under 510(k) number K213189.

Who is the listed applicant for Wrist-type Fully Automatic Digital Blood Pressure Monitor?

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

What is the FDA product code for Wrist-type Fully Automatic Digital Blood Pressure Monitor?

The FDA product code for Wrist-type Fully Automatic Digital Blood Pressure Monitor 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.

NCT07558291Continuous Glucose Monitoring Versus Self-Monitoring of Blood Glucose in Women With Gestational DiabetesNOT_YET_RECRUITINGNCT06508619Blood Pressure Treatment by the Corsano CardioWatch 287-2 Evaluation StudyCOMPLETEDNCT07284511A Clinical Trial Using Tirzepatide to Help Adults With Type 1 Diabetes Automatically Control Their Blood SugarRECRUITINGNCT07562971Focused Ultrasound Blood-Brain Barrier Opening in Pontine Diffuse Midline Glioma to Enhance Temozolomide Therapy: Pilot Feasibility Study (FIDES)NOT_YET_RECRUITINGNCT07595289DP-DCT 1.0：A Comparative Clinical Study on the Effect of Dapagliflozin Combined With CGM Versus SMBG on Glycemic Control in Patients With Type 2 Diabetes Mellitus Based on the DP-DCT PlatformNOT_YET_RECRUITINGNCT07633886Multi-Centre Based Evaluation of the Performance and Safety of the Corsano CardioWatch 287-2 Blood Pressure Monitoring Device at Wrist Against BP-Cuff Measurements (COR-BP)NOT_YET_RECRUITING

Other records listing Joytech Healthcare Co. , Ltd. 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.

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)K252501Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62E3B, DBP-62E2B, DBP-62E1B, DBP-61E3, DBP-61E2, DBP-61E1, DBP-61D7G, DBP-6281L, DBP-6282L, DBP-6285L)K252685Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P, DBP-63D2L, DBP-63D2L-P, DBP-61D9L,DBP-61D9L-P, DBP-63D9L, DBP-63D9L-P, DBP-62F4L, DBP-62F4B, DBP-61F4,DBP-61F4L, DBP-61F4-P, DBP-61F4L-P, DBP-62F4L-P, DBP-62F4B-P)K243468Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103)K250548Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186)K241431Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62D0L, DBP-62D0B, DBP-61D0, DBP-61D0L, DBP-6293L, DBP-6293B, DBP-6193)

View all 23 devices →

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

View on FDA Database →

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

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