Freestyle Flex
K号: K191653 · 2019-10-17
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申请人Medela AG
决定日期2019-10-17
产品代码HGX
咨询委员会OB
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决定实质等同
器械摘要
Freestyle Flex is the device name listed in this FDA 510(k) record. The listed applicant is Medela AG. It received FDA 510(k) clearance on 2019-10-17 under 510(k) number K191653. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Freestyle Flex?
Freestyle Flex is a medical device that received FDA 510(k) clearance on 2019-10-17. The listed applicant is Medela AG. The 510(k) number is K191653.
When did Freestyle Flex receive FDA 510(k) clearance?
Freestyle Flex received FDA 510(k) clearance on 2019-10-17, under 510(k) number K191653.
Who is the listed applicant for Freestyle Flex?
The FDA 510(k) record lists Medela AG as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Freestyle Flex?
The FDA product code for Freestyle Flex is HGX.
相关临床试验
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列明Medela AG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。
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相关器械（代码：HGX）
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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