FDA 510(k)

V-Patch Cardiac Monitor

Número K: K222842 · 2022-10-20

RequerenteShandong Corecare Technology Limited

Data da decisão2022-10-20

Código do produtoDXH

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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