BEAR 2 Body
K号: K232242 · 2024-05-13
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申请人Foreo, Inc.
决定日期2024-05-13
产品代码NFO
咨询委员会NE
请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同
器械摘要
BEAR 2 Body is the device name listed in this FDA 510(k) record. The listed applicant is Foreo, Inc.. It received FDA 510(k) clearance on 2024-05-13 under 510(k) number K232242. The device is classified under product code NFO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the BEAR 2 Body?
BEAR 2 Body is a medical device that received FDA 510(k) clearance on 2024-05-13. The listed applicant is Foreo, Inc.. The 510(k) number is K232242.
When did BEAR 2 Body receive FDA 510(k) clearance?
BEAR 2 Body received FDA 510(k) clearance on 2024-05-13, under 510(k) number K232242.
Who is the listed applicant for BEAR 2 Body?
The FDA 510(k) record lists Foreo, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for BEAR 2 Body?
The FDA product code for BEAR 2 Body is NFO.
列明Foreo, Inc.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：NFO）
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
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