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FDA 510(k)

STOPWET離子電泳儀(SW01)

K 號:K242041 · 2025-04-01

決定日期2025-04-01
產品代碼EGJ
諮詢委員會PM
決定相當於

器材摘要

STOPWET iontophoresis apparatus (SW01) is the device name listed in this FDA 510(k) record. The listed applicant is Taiwan Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2025-04-01 under 510(k) number K242041. The device is classified under product code EGJ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the STOPWET iontophoresis apparatus (SW01)?

STOPWET iontophoresis apparatus (SW01) is a medical device that received FDA 510(k) clearance on 2025-04-01. The listed applicant is Taiwan Medical Electronics Co., Ltd.. The 510(k) number is K242041.

When did STOPWET iontophoresis apparatus (SW01) receive FDA 510(k) clearance?

STOPWET iontophoresis apparatus (SW01) received FDA 510(k) clearance on 2025-04-01, under 510(k) number K242041.

Who is the listed applicant for STOPWET iontophoresis apparatus (SW01)?

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

What is the FDA product code for STOPWET iontophoresis apparatus (SW01)?

The FDA product code for STOPWET iontophoresis apparatus (SW01) is EGJ.

相關臨床試驗

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相關器械(代碼:EGJ)

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。

官方來源

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