GENESIS(MS-P02-GEN)
K号: K240843 · 2024-10-07
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决定日期2024-10-07
产品代码ILK
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
GENESIS (MS-P02-GEN) is the device name listed in this FDA 510(k) record. The listed applicant is Climbing Steps, Inc.. It received FDA 510(k) clearance on 2024-10-07 under 510(k) number K240843. The device is classified under product code ILK. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the GENESIS (MS-P02-GEN)?
GENESIS (MS-P02-GEN) is a medical device that received FDA 510(k) clearance on 2024-10-07. The listed applicant is Climbing Steps, Inc.. The 510(k) number is K240843.
When did GENESIS (MS-P02-GEN) receive FDA 510(k) clearance?
GENESIS (MS-P02-GEN) received FDA 510(k) clearance on 2024-10-07, under 510(k) number K240843.
Who is the listed applicant for GENESIS (MS-P02-GEN)?
The FDA 510(k) record lists Climbing Steps, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for GENESIS (MS-P02-GEN)?
The FDA product code for GENESIS (MS-P02-GEN) is ILK.
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:ILK)
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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