FDA 510(k)

AT-Patch 心電圖分析系統

K 號：K203638 · 2022-10-12

決定日期2022-10-12

產品代碼DSH

諮詢委員會履歷

決定相當於

器材摘要

AT-Patch ECG Analysis System is the device name listed in this FDA 510(k) record. The listed applicant is Atsens Co., Ltd.. It received FDA 510(k) clearance on 2022-10-12 under 510(k) number K203638. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AT-Patch ECG Analysis System?

AT-Patch ECG Analysis System is a medical device that received FDA 510(k) clearance on 2022-10-12. The listed applicant is Atsens Co., Ltd.. The 510(k) number is K203638.

When did AT-Patch ECG Analysis System receive FDA 510(k) clearance?

AT-Patch ECG Analysis System received FDA 510(k) clearance on 2022-10-12, under 510(k) number K203638.

Who is the listed applicant for AT-Patch ECG Analysis System?

The FDA 510(k) record lists Atsens Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AT-Patch ECG Analysis System?

The FDA product code for AT-Patch ECG Analysis System is DSH.

其他以 Atsens Co., Ltd. 為申請人之記錄

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K242583AT-Patch (ATP-C130/ATP-C70)

相關器械（代碼：DSH）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K260157LifeLens生理監測器LifeLens Technologies, Inc.K252389節奏主將心電圖貼片（HM-15BB-AX，HM-15BW-AX，HM-15BW-DX）Smwmed, Inc.K253293VitaloJAK 诊所（型號 7100）Vitalograph , Ltd.K243650Zio® 監護器（DFG0001）iRhythm Technologies, Inc.K243603AeviceMDAevice Health Pte. , Ltd.K242583AT-Patch (ATP-C130/ATP-C70)Atsens Co., Ltd.

官方來源

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