Basic，Dominant Flex
K号: K170329 · 2017-03-24
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器械摘要
Basic, Dominant Flex is the device name listed in this FDA 510(k) record. The listed applicant is Modela AG. It received FDA 510(k) clearance on 2017-03-24 under 510(k) number K170329. The device is classified under product code QPB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Basic, Dominant Flex?
Basic, Dominant Flex is a medical device that received FDA 510(k) clearance on 2017-03-24. The listed applicant is Modela AG. The 510(k) number is K170329.
When did Basic, Dominant Flex receive FDA 510(k) clearance?
Basic, Dominant Flex received FDA 510(k) clearance on 2017-03-24, under 510(k) number K170329.
Who is the listed applicant for Basic, Dominant Flex?
The FDA 510(k) record lists Modela AG as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Basic, Dominant Flex?
The FDA product code for Basic, Dominant Flex is QPB.
相关临床试验
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：QPB）
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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