FDA 510(k)

V-Patch Cardiac Monitor

Номер K: K222842 · 2022-10-20

ЗаявительShandong Corecare Technology Limited

Дата решения2022-10-20

Код продуктаDXH

Консультативный комитетCV

РешениеSubstantially Equivalent

Описание устройства

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.

Часто задаваемые вопросы

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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: DXH)

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.

Официальный источник

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