FDA 510(k)

CIV-Clear 盖

K号: K211270 · 2021-09-13

决定日期2021-09-13

产品代码ITX

咨询委员会RA

决定实质等同

器械摘要

CIV-Clear cover 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 2021-09-13 under 510(k) number K211270. 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 CIV-Clear cover?

CIV-Clear cover is a medical device that received FDA 510(k) clearance on 2021-09-13. The listed applicant is CIVCO Medical Instruments Co., Inc.. The 510(k) number is K211270.

When did CIV-Clear cover receive FDA 510(k) clearance?

CIV-Clear cover received FDA 510(k) clearance on 2021-09-13, under 510(k) number K211270.

Who is the listed applicant for CIV-Clear cover?

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 CIV-Clear cover?

The FDA product code for CIV-Clear cover 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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