FDA 510(k)

ControlRad Select 型号 Z, ControlRad Trace 型号 8, ControlRad Trace 型号 9

K号: K211782 · 2021-07-01

决定日期2021-07-01

产品代码OWB

咨询委员会RA

决定实质等同

器械摘要

ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9 is the device name listed in this FDA 510(k) record. The listed applicant is Controlrad, Inc.. It received FDA 510(k) clearance on 2021-07-01 under 510(k) number K211782. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9?

ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9 is a medical device that received FDA 510(k) clearance on 2021-07-01. The listed applicant is Controlrad, Inc.. The 510(k) number is K211782.

When did ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9 receive FDA 510(k) clearance?

ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9 received FDA 510(k) clearance on 2021-07-01, under 510(k) number K211782.

Who is the listed applicant for ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9?

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 Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9?

The FDA product code for ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9 is OWB.

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 K202431ControlRad Select 型号 Z K200663ControlRad Trace Model 9 K200238ControlRad 无菌盖 K183109ControlRad Trace Model 8

官方来源

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