FDA 510(k)

ControlRad 无菌盖

K号: K200238 · 2020-04-26

决定日期2020-04-26

产品代码KKX

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决定实质等同

器械摘要

ControlRad Sterile Cover is the device name listed in this FDA 510(k) record. The listed applicant is Controlrad, Inc.. It received FDA 510(k) clearance on 2020-04-26 under 510(k) number K200238. The device is classified under product code KKX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ControlRad Sterile Cover?

ControlRad Sterile Cover is a medical device that received FDA 510(k) clearance on 2020-04-26. The listed applicant is Controlrad, Inc.. The 510(k) number is K200238.

When did ControlRad Sterile Cover receive FDA 510(k) clearance?

ControlRad Sterile Cover received FDA 510(k) clearance on 2020-04-26, under 510(k) number K200238.

Who is the listed applicant for ControlRad Sterile Cover?

The FDA 510(k) record lists Controlrad, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ControlRad Sterile Cover?

The FDA product code for ControlRad Sterile Cover is KKX.

列明Controlrad, 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。

K213455ControlRad Select 型号 Z K211782ControlRad Select 型号 Z, ControlRad Trace 型号 8, ControlRad Trace 型号 9 K202431ControlRad Select 型号 Z K200663ControlRad Trace Model 9 K183109ControlRad Trace Model 8

官方来源

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