Keeogo皮肤骨骼系统
K号: K201539 · 2020-09-09
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决定日期2020-09-09
产品代码PHL
咨询委员会PM
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决定实质等同
器械摘要
Keeogo Dermoskeleton System is the device name listed in this FDA 510(k) record. The listed applicant is B-Temia, Inc.. It received FDA 510(k) clearance on 2020-09-09 under 510(k) number K201539. The device is classified under product code PHL. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Keeogo Dermoskeleton System?
Keeogo Dermoskeleton System is a medical device that received FDA 510(k) clearance on 2020-09-09. The listed applicant is B-Temia, Inc.. The 510(k) number is K201539.
When did Keeogo Dermoskeleton System receive FDA 510(k) clearance?
Keeogo Dermoskeleton System received FDA 510(k) clearance on 2020-09-09, under 510(k) number K201539.
Who is the listed applicant for Keeogo Dermoskeleton System?
The FDA 510(k) record lists B-Temia, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Keeogo Dermoskeleton System?
The FDA product code for Keeogo Dermoskeleton System is PHL.
相关临床试验
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相关器械（代码：PHL）
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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