FDA 510(k)

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

K 號：K242583 · 2025-05-02

決定日期2025-05-02

產品代碼DSH

諮詢委員會履歷

決定相當於

器材摘要

AT-Patch (ATP-C130/ATP-C70) 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 2025-05-02 under 510(k) number K242583. 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 (ATP-C130/ATP-C70)?

AT-Patch (ATP-C130/ATP-C70) is a medical device that received FDA 510(k) clearance on 2025-05-02. The listed applicant is Atsens Co., Ltd.. The 510(k) number is K242583.

When did AT-Patch (ATP-C130/ATP-C70) receive FDA 510(k) clearance?

AT-Patch (ATP-C130/ATP-C70) received FDA 510(k) clearance on 2025-05-02, under 510(k) number K242583.

Who is the listed applicant for AT-Patch (ATP-C130/ATP-C70)?

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 (ATP-C130/ATP-C70)?

The FDA product code for AT-Patch (ATP-C130/ATP-C70) is DSH.

其他以 Atsens Co., Ltd. 為申請人之記錄

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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。

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官方來源

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