OssGuide
K号: K200623 · 2020-10-02
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决定日期2020-10-02
产品代码NPL
咨询委员会DE
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决定实质等同
器械摘要
OssGuide is the device name listed in this FDA 510(k) record. The listed applicant is Sk Bioland Co., Ltd.. It received FDA 510(k) clearance on 2020-10-02 under 510(k) number K200623. The device is classified under product code NPL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the OssGuide?
OssGuide is a medical device that received FDA 510(k) clearance on 2020-10-02. The listed applicant is Sk Bioland Co., Ltd.. The 510(k) number is K200623.
When did OssGuide receive FDA 510(k) clearance?
OssGuide received FDA 510(k) clearance on 2020-10-02, under 510(k) number K200623.
Who is the listed applicant for OssGuide?
The FDA 510(k) record lists Sk Bioland Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OssGuide?
The FDA product code for OssGuide is NPL.
相关临床试验
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相关器械（代码：NPL）
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。
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官方来源
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