geko™ W-2
K号: K193045 · 2020-01-18
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决定日期2020-01-18
产品代码IPF
咨询委员会PM
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决定实质等同
器械摘要
geko™ W-2 is the device name listed in this FDA 510(k) record. The listed applicant is Firstkind Limited. It received FDA 510(k) clearance on 2020-01-18 under 510(k) number K193045. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the geko™ W-2?
geko™ W-2 is a medical device that received FDA 510(k) clearance on 2020-01-18. The listed applicant is Firstkind Limited. The 510(k) number is K193045.
When did geko™ W-2 receive FDA 510(k) clearance?
geko™ W-2 received FDA 510(k) clearance on 2020-01-18, under 510(k) number K193045.
Who is the listed applicant for geko™ W-2?
The FDA 510(k) record lists Firstkind Limited as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for geko™ W-2?
The FDA product code for geko™ W-2 is IPF.
列明Firstkind Limited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：IPF）
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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