STOPWET 离子导入装置 (SW01)
K号: K242041 · 2025-04-01
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决定日期2025-04-01
产品代码EGJ
咨询委员会PM
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决定实质等同
器械摘要
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.
常见问题
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.
相关临床试验
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相关器械（代码：EGJ）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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