geko W-2
K号: K212762 · 2021-11-29
广告
决定日期2021-11-29
产品代码IPF
咨询委员会PM
请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。
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 2021-11-29 under 510(k) number K212762. 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 2021-11-29. The listed applicant is Firstkind Limited. The 510(k) number is K212762.
When did geko W-2 receive FDA 510(k) clearance?
geko W-2 received FDA 510(k) clearance on 2021-11-29, under 510(k) number K212762.
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。
广告