FDA 510(k)

V-Patch Cardiac Monitor

K-Number: K222842 · 2022-10-20

ApplicantShandong Corecare Technology Limited

Decision Date2022-10-20

Product CodeDXH

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

V-Patch Cardiac Monitor is a medical device manufactured by Shandong Corecare Technology Limited. It received FDA 510(k) clearance on 2022-10-20 under approval number K222842. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the V-Patch Cardiac Monitor?

V-Patch Cardiac Monitor is a medical device that received FDA 510(k) clearance on 2022-10-20. It is manufactured by Shandong Corecare Technology Limited. The 510(k) number is K222842.

When was V-Patch Cardiac Monitor approved by the FDA?

V-Patch Cardiac Monitor received FDA 510(k) clearance on 2022-10-20, under approval number K222842.

What company makes V-Patch Cardiac Monitor?

V-Patch Cardiac Monitor is manufactured by Shandong Corecare Technology Limited.

What is the FDA product code for V-Patch Cardiac Monitor?

The FDA product code for V-Patch Cardiac Monitor is DXH. This falls under the Hematology category.

Related Clinical Trials

NCT03262415 PRECISION Study: Evaluating the Accuracy of the LabPatch Continuous Glucose Monitor COMPLETED NCT06232876 Continuous Versus Intermittent Ward Monitoring NOT_YET_RECRUITING NCT07612085 A Wearable Biosensor Patch for Non-Invasive Monitoring for Patients Undergoing Abdominal or Chest Surgery NOT_YET_RECRUITING NCT01621594 Evaluating New Radiation Techniques for Cardiovascular Imaging RECRUITING NCT06172699 Assert-IQ Implantable Cardiac Monitor (ICM) Post Market Study COMPLETED NCT07240831 Accuracy of a Cuffless Photoplethysmography (PPG) Chest-Patch Monitor for 24-hour Ambulatory Blood Pressure Monitoring (ABPM) RECRUITING

Related Devices (Code: DXH)

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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.