FlexBand; FlexPatch; FlexBand Plus
K号: K230316 · 2023-05-26
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决定日期2023-05-26
产品代码OWW
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
FlexBand; FlexPatch; FlexBand Plus is the device name listed in this FDA 510(k) record. The listed applicant is International Life Sciences. It received FDA 510(k) clearance on 2023-05-26 under 510(k) number K230316. The device is classified under product code OWW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the FlexBand; FlexPatch; FlexBand Plus?
FlexBand; FlexPatch; FlexBand Plus is a medical device that received FDA 510(k) clearance on 2023-05-26. The listed applicant is International Life Sciences. The 510(k) number is K230316.
When did FlexBand; FlexPatch; FlexBand Plus receive FDA 510(k) clearance?
FlexBand; FlexPatch; FlexBand Plus received FDA 510(k) clearance on 2023-05-26, under 510(k) number K230316.
Who is the listed applicant for FlexBand; FlexPatch; FlexBand Plus?
The FDA 510(k) record lists International Life Sciences as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for FlexBand; FlexPatch; FlexBand Plus?
The FDA product code for FlexBand; FlexPatch; FlexBand Plus is OWW.
相关临床试验
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列明International Life Sciences为申报人的其他记录
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相关器械（代码：OWW）
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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