FDA 510(k)

V-Patch Cardiac Monitor

K番号: K222842 · 2022-10-20

決定日2022-10-20

製品コードDXH

諮問委員会以下は、提供された医療機器規制テキストの日本語訳です。 --- **政策：medical-regulatory-v1** --- [ここに原文が記載されています] --- **会社名/製品名**：[ここに会社名または製品名が記載されています] **FDA**：食品医薬品局 **510(k)**：510(k)届出 **PMA**：プレマーケティング評価届出 **NCT**：臨床試験登録番号 **PMID**：PubMed ID **識別子**：[ここに識別子が記載されています] **URL**：[ここにURLが記載されています]

決定大幅同等

医療機器の概要

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.

よくある質問

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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V-Patch Cardiac Monitor

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：DXH）

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