Hystero-V 宫腔镜
K号: K202445 · 2021-11-23
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决定日期2021-11-23
产品代码HIH
咨询委员会OB
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决定实质等同
器械摘要
Hystero-V Hysteroscope is the device name listed in this FDA 510(k) record. The listed applicant is Hysterovue, Inc.. It received FDA 510(k) clearance on 2021-11-23 under 510(k) number K202445. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Hystero-V Hysteroscope?
Hystero-V Hysteroscope is a medical device that received FDA 510(k) clearance on 2021-11-23. The listed applicant is Hysterovue, Inc.. The 510(k) number is K202445.
When did Hystero-V Hysteroscope receive FDA 510(k) clearance?
Hystero-V Hysteroscope received FDA 510(k) clearance on 2021-11-23, under 510(k) number K202445.
Who is the listed applicant for Hystero-V Hysteroscope?
The FDA 510(k) record lists Hysterovue, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Hystero-V Hysteroscope?
The FDA product code for Hystero-V Hysteroscope is HIH.
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相关器械（代码：HIH）
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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