UINCARE家用
K号: K172882 · 2018-05-10
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决定日期2018-05-10
产品代码LXJ
咨询委员会PM
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决定实质等同
器械摘要
UINCARE HOME is the device name listed in this FDA 510(k) record. The listed applicant is Uincare Corp.. It received FDA 510(k) clearance on 2018-05-10 under 510(k) number K172882. The device is classified under product code LXJ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the UINCARE HOME?
UINCARE HOME is a medical device that received FDA 510(k) clearance on 2018-05-10. The listed applicant is Uincare Corp.. The 510(k) number is K172882.
When did UINCARE HOME receive FDA 510(k) clearance?
UINCARE HOME received FDA 510(k) clearance on 2018-05-10, under 510(k) number K172882.
Who is the listed applicant for UINCARE HOME?
The FDA 510(k) record lists Uincare Corp. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for UINCARE HOME?
The FDA product code for UINCARE HOME is LXJ.
相关临床试验
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相关器械（代码：LXJ）
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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