Scanmate Flex
K号: K171301 · 2017-07-31
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器械摘要
Scanmate Flex is the device name listed in this FDA 510(k) record. The listed applicant is Dgh Technology, Inc.. It received FDA 510(k) clearance on 2017-07-31 under 510(k) number K171301. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Scanmate Flex?
Scanmate Flex is a medical device that received FDA 510(k) clearance on 2017-07-31. The listed applicant is Dgh Technology, Inc.. The 510(k) number is K171301.
When did Scanmate Flex receive FDA 510(k) clearance?
Scanmate Flex received FDA 510(k) clearance on 2017-07-31, under 510(k) number K171301.
Who is the listed applicant for Scanmate Flex?
The FDA 510(k) record lists Dgh Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Scanmate Flex?
The FDA product code for Scanmate Flex is IYO.
相关临床试验
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相关器械(代码:IYO)
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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