FDA 510(k)

ControlRad 선택 모델 Z, ControlRad 트레이스 모델 8, ControlRad 트레이스 모델 9

K-번호: K211782 · 2021-07-01

결정일2021-07-01

제품 코드OWB

자문 위원회RA

결정Substantially Equivalent

기기 요약

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.

자주 묻는 질문

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.

Controlrad, Inc.를 신청인으로 등재한 기타 기록

K213455ControlRad 선택 모델 Z K202431ControlRad 선택 모델 Z K200663ControlRad 트레이스 모델 9 K200238ControlRad 무균 커버 K183109ControlRad 트레이스 모델 8

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