FDA 510(k)

VitroPRO

K号: K222052 · 2022-11-22

决定日期2022-11-22

产品代码ITX

咨询委员会RA

决定实质等同

器械摘要

VitroPRO is the device name listed in this FDA 510(k) record. The listed applicant is CIVCO Medical Instruments Co., Inc.. It received FDA 510(k) clearance on 2022-11-22 under 510(k) number K222052. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the VitroPRO?

VitroPRO is a medical device that received FDA 510(k) clearance on 2022-11-22. The listed applicant is CIVCO Medical Instruments Co., Inc.. The 510(k) number is K222052.

When did VitroPRO receive FDA 510(k) clearance?

VitroPRO received FDA 510(k) clearance on 2022-11-22, under 510(k) number K222052.

Who is the listed applicant for VitroPRO?

FDA 510(k)记录将CIVCO Medical Instruments Co., Inc.列为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for VitroPRO?

The FDA product code for VitroPRO is ITX.

列明CIVCO Medical Instruments Co., Inc.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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官方来源

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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。