KIDScore D3
K号: K182798 · 2019-07-19
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决定日期2019-07-19
产品代码PBH
咨询委员会OB
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决定实质等同
器械摘要
KIDScore D3 is the device name listed in this FDA 510(k) record. The listed applicant is Vitrolife A/S. It received FDA 510(k) clearance on 2019-07-19 under 510(k) number K182798. The device is classified under product code PBH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the KIDScore D3?
KIDScore D3 is a medical device that received FDA 510(k) clearance on 2019-07-19. The listed applicant is Vitrolife A/S. The 510(k) number is K182798.
When did KIDScore D3 receive FDA 510(k) clearance?
KIDScore D3 received FDA 510(k) clearance on 2019-07-19, under 510(k) number K182798.
Who is the listed applicant for KIDScore D3?
The FDA 510(k) record lists Vitrolife A/S as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for KIDScore D3?
The FDA product code for KIDScore D3 is PBH.
相关临床试验
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列明Vitrolife A/S为申报人的其他记录
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相关器械（代码：PBH）
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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