E-PEN (E-PEN)
K号: K243143 · 2025-04-07
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决定日期2025-04-07
产品代码QAI
咨询委员会SU
请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同
器械摘要
E-PEN (E-PEN) is the device name listed in this FDA 510(k) record. The listed applicant is Bomtech Electronics Co., Ltd.. It received FDA 510(k) clearance on 2025-04-07 under 510(k) number K243143. The device is classified under product code QAI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the E-PEN (E-PEN)?
E-PEN (E-PEN) is a medical device that received FDA 510(k) clearance on 2025-04-07. The listed applicant is Bomtech Electronics Co., Ltd.. The 510(k) number is K243143.
When did E-PEN (E-PEN) receive FDA 510(k) clearance?
E-PEN (E-PEN) received FDA 510(k) clearance on 2025-04-07, under 510(k) number K243143.
Who is the listed applicant for E-PEN (E-PEN)?
The FDA 510(k) record lists Bomtech Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for E-PEN (E-PEN)?
The FDA product code for E-PEN (E-PEN) is QAI.
列明Bomtech Electronics Co., Ltd.为申报人的其他记录
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。
相关器械（代码：QAI）
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。
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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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