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FDA 510(k)

Wrist Electronic Blood Pressure Monitor(Model FC-BP200, FC-BP201, FC-BP210,FC-BP211, FC-BP220, FC-BP221)

K-Number: K231367 · 2023-09-18

ApplicantShenzhen Finicare Co., Ltd.
Decision Date2023-09-18
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Wrist Electronic Blood Pressure Monitor(Model FC-BP200, FC-BP201, FC-BP210,FC-BP211, FC-BP220, FC-BP221) is a medical device manufactured by Shenzhen Finicare Co., Ltd.. It received FDA 510(k) clearance on 2023-09-18 under approval number K231367. 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 Electronic Blood Pressure Monitor(Model FC-BP200, FC-BP201, FC-BP210,FC-BP211, FC-BP220, FC-BP221)?

Wrist Electronic Blood Pressure Monitor(Model FC-BP200, FC-BP201, FC-BP210,FC-BP211, FC-BP220, FC-BP221) is a medical device that received FDA 510(k) clearance on 2023-09-18. It is manufactured by Shenzhen Finicare Co., Ltd.. The 510(k) number is K231367.

When was Wrist Electronic Blood Pressure Monitor(Model FC-BP200, FC-BP201, FC-BP210,FC-BP211, FC-BP220, FC-BP221) approved by the FDA?

Wrist Electronic Blood Pressure Monitor(Model FC-BP200, FC-BP201, FC-BP210,FC-BP211, FC-BP220, FC-BP221) received FDA 510(k) clearance on 2023-09-18, under approval number K231367.

What company makes Wrist Electronic Blood Pressure Monitor(Model FC-BP200, FC-BP201, FC-BP210,FC-BP211, FC-BP220, FC-BP221)?

Wrist Electronic Blood Pressure Monitor(Model FC-BP200, FC-BP201, FC-BP210,FC-BP211, FC-BP220, FC-BP221) is manufactured by Shenzhen Finicare Co., Ltd..

What is the FDA product code for Wrist Electronic Blood Pressure Monitor(Model FC-BP200, FC-BP201, FC-BP210,FC-BP211, FC-BP220, FC-BP221)?

The FDA product code for Wrist Electronic Blood Pressure Monitor(Model FC-BP200, FC-BP201, FC-BP210,FC-BP211, FC-BP220, FC-BP221) is DXN.

Related Clinical Trials

NCT07260890 Paired Comparison of SVV and PVI Accuracy COMPLETED NCT07614139 Continuous Glucose Monitoring Alerts, Accuracy, and Patient Outcomes in Adults With Inherited Metabolic Disorders COMPLETED NCT07613762 High-Flow Nasal Cannula on Exercise Tolerance in Heart Failure Patients Undergoing Cardiac Rehabilitation. NOT_YET_RECRUITING NCT06940752 VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters ENROLLING_BY_INVITATION NCT07499128 Continuous Temperature Monitoring (CTM) for Cytokine Release Syndrome (CRS), an Immune-Related Adverse Event ENROLLING_BY_INVITATION NCT07099092 Causal Mechanisms of Odor-Guided Behavior in Humans NOT_YET_RECRUITING

Related PubMed Literature

PMID: 41836285 A Case Study of AI-Enabled Software as a Medical Device Cleared by the FDA for Assessing Hemorrhage Risk Index (APPRAISE-HRI) after Trauma. NEJM AI (2025) PMID: 41623865 Case Report: Hypertensive encephalopathy presents with complex types of sleep breathing events. Frontiers in cardiovascular medicine (2025) PMID: 41501972 First Application of an Eddy-Scale Hemolysis Model to the Food and Drug Administration Nozzle Using Computational Fluid Dynamics. ASAIO journal (American Society for Artificial Internal Organs : 1992) (2026)

Other Devices by Shenzhen Finicare Co., Ltd.

K181215Infrared Thermometer K220113Upper Arm Electronic Blood Pressure Monitor(Model FC-BP100,FC-BP101,FC-BP102,FC-BP110,FC-BP111,FC-BP112) K242721Upper Arm Electronic Blood Pressure Monitor (FC-BP103, FC-BP106, FC-BP113, FC-BP120, FC-BP121, FC-BP130, FC-BP131) 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)

Related Devices (Code: DXN)

K162092Evolv Model BP7000 Upper Arm Blood Pressure MonitorOmron Healthcare, Inc. K161708Arm automatic blood pressure monitorShenzhen Pump Medical System Co., Ltd. K162230Fully Automatic Electronic Blood Pressure MonitorAdon Health Co., Ltd. K160349Electronic SphygmomanometerGuangdong Biolight Meditech Co., Ltd. K161846Automatic Arm Bluetooth Blood Pressure MonitorTruly Instrument Limited K161886Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure DeviceGuangdong Transtek Medical Electronics Co., Ltd.

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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