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FDA 510(k)

Upper Arm Electronic Blood Pressure Monitor(Model FC-BP100,FC-BP101,FC-BP102,FC-BP110,FC-BP111,FC-BP112)

K-Number: K220113 · 2022-05-31

ApplicantShenzhen Finicare Co., Ltd.
Decision Date2022-05-31
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Upper Arm Electronic Blood Pressure Monitor(Model FC-BP100,FC-BP101,FC-BP102,FC-BP110,FC-BP111,FC-BP112) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Finicare Co., Ltd.. It received FDA 510(k) clearance on 2022-05-31 under 510(k) number K220113. 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 Upper Arm Electronic Blood Pressure Monitor(Model FC-BP100,FC-BP101,FC-BP102,FC-BP110,FC-BP111,FC-BP112)?

Upper Arm Electronic Blood Pressure Monitor(Model FC-BP100,FC-BP101,FC-BP102,FC-BP110,FC-BP111,FC-BP112) is a medical device that received FDA 510(k) clearance on 2022-05-31. The listed applicant is Shenzhen Finicare Co., Ltd.. The 510(k) number is K220113.

When did Upper Arm Electronic Blood Pressure Monitor(Model FC-BP100,FC-BP101,FC-BP102,FC-BP110,FC-BP111,FC-BP112) receive FDA 510(k) clearance?

Upper Arm Electronic Blood Pressure Monitor(Model FC-BP100,FC-BP101,FC-BP102,FC-BP110,FC-BP111,FC-BP112) received FDA 510(k) clearance on 2022-05-31, under 510(k) number K220113.

Who is the listed applicant for Upper Arm Electronic Blood Pressure Monitor(Model FC-BP100,FC-BP101,FC-BP102,FC-BP110,FC-BP111,FC-BP112)?

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

What is the FDA product code for Upper Arm Electronic Blood Pressure Monitor(Model FC-BP100,FC-BP101,FC-BP102,FC-BP110,FC-BP111,FC-BP112)?

The FDA product code for Upper Arm Electronic Blood Pressure Monitor(Model FC-BP100,FC-BP101,FC-BP102,FC-BP110,FC-BP111,FC-BP112) 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.

NCT07240831Accuracy of a Cuffless Photoplethysmography (PPG) Chest-Patch Monitor for 24-hour Ambulatory Blood Pressure Monitoring (ABPM)RECRUITINGNCT07523269WEARABLE-BP: Wearable Everyday Automated Readings to Enable Assessment of Blood Pressure ControlRECRUITINGNCT07694570Feasibility Study: Continuous ECG and Blood Pressure Monitoring With the M2VS Sensor SystemNOT_YET_RECRUITINGNCT07696910Perioperative Hypoglycemia in Diabetic Patients Undergoing Vitrectomy: a Masked CGM Prospective Observational StudyNOT_YET_RECRUITINGNCT06969560WeRoaM: Wearable Remote Monitoring in Heart FailureRECRUITINGNCT06973590Blood Flow Restriction and Transcutaneous Electrical Nerve Stimulation on Motor Function in StrokeRECRUITING

Other records listing Shenzhen Finicare 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.

K252769Upper Arm Electronic Blood Pressure Monitor (FC-BP107, FC-BP123, FC-BP125, FC-BP126, FC-BP127, FC-BP116)K243136Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209)K242721Upper Arm Electronic Blood Pressure Monitor (FC-BP103, FC-BP106, FC-BP113, FC-BP120, FC-BP121, FC-BP130, FC-BP131)K231367Wrist Electronic Blood Pressure Monitor(Model FC-BP200, FC-BP201, FC-BP210,FC-BP211, FC-BP220, FC-BP221)K181215Infrared Thermometer

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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