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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 the device name listed in this FDA 510(k) record. The listed applicant is Shandong Corecare Technology Limited. It received FDA 510(k) clearance on 2022-10-20 under 510(k) 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. The listed applicant is Shandong Corecare Technology Limited. The 510(k) number is K222842.

When did V-Patch Cardiac Monitor receive FDA 510(k) clearance?

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

Who is the listed applicant for V-Patch Cardiac Monitor?

The FDA 510(k) record lists Shandong Corecare Technology Limited as the applicant. This does not by itself establish the device manufacturer.

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

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.

NCT06699056AI-Enabled Direct-from-ECG Ejection Fraction (EF) Severity Assessment Using COR ECG Wearable MonitorRECRUITINGNCT077285527-Day MEMO Patch Monitoring for Arrhythmia Detection in Patients With PalpitationsCOMPLETEDNCT07776964Monitoring for CardioToxicity Using WeArable deVices While Undergoing cancEr Treatments (MCT-WAVE)NOT_YET_RECRUITING

Related Devices (Code: DXH)

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.

K250233PreemptiveAI Clinical SDKMeasure Labs, Inc. (Dba Preemptiveai, Inc.)K250258HeartBeam AIMIGo with 12-L ECG Synthesis Software SystemHeartbeam, Inc.K243438MEMO Patch M (MPT-E08R-UNC01)Huinno Co., Ltd.K243981Hexoskin Medical System (7100-00016)Carre Technologies, Inc.K243003VitalSigns 1-Lead Holter (VSH101)VitalSigns Technology Co., Ltd.K233521QT ECG (QTERD100)QT Medical, Inc.

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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