Gx-IVF, Gx-TL, Gx-MOPS PLUS
K号: K202862 · 2021-05-14
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决定日期2021-05-14
产品代码MQL
咨询委员会OB
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决定实质等同
器械摘要
Gx-IVF, Gx-TL, Gx-MOPS PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Vitrolife Sweden AB. It received FDA 510(k) clearance on 2021-05-14 under 510(k) number K202862. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Gx-IVF, Gx-TL, Gx-MOPS PLUS?
Gx-IVF, Gx-TL, Gx-MOPS PLUS is a medical device that received FDA 510(k) clearance on 2021-05-14. The listed applicant is Vitrolife Sweden AB. The 510(k) number is K202862.
When did Gx-IVF, Gx-TL, Gx-MOPS PLUS receive FDA 510(k) clearance?
Gx-IVF, Gx-TL, Gx-MOPS PLUS received FDA 510(k) clearance on 2021-05-14, under 510(k) number K202862.
Who is the listed applicant for Gx-IVF, Gx-TL, Gx-MOPS PLUS?
The FDA 510(k) record lists Vitrolife Sweden AB as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Gx-IVF, Gx-TL, Gx-MOPS PLUS?
The FDA product code for Gx-IVF, Gx-TL, Gx-MOPS PLUS is MQL.
列明Vitrolife Sweden AB为申报人的其他记录
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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相关器械（代码：MQL）
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
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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