FDA 510(k)

LINACwatch, LinacView

K-번호: K172534 · 2017-10-27

결정일2017-10-27

제품 코드IYE

자문 위원회RA

결정Substantially Equivalent

기기 요약

LINACwatch, LinacView is the device name listed in this FDA 510(k) record. The listed applicant is Qualiformed Sarl. It received FDA 510(k) clearance on 2017-10-27 under 510(k) number K172534. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the LINACwatch, LinacView?

LINACwatch, LinacView is a medical device that received FDA 510(k) clearance on 2017-10-27. The listed applicant is Qualiformed Sarl. The 510(k) number is K172534.

When did LINACwatch, LinacView receive FDA 510(k) clearance?

LINACwatch, LinacView received FDA 510(k) clearance on 2017-10-27, under 510(k) number K172534.

Who is the listed applicant for LINACwatch, LinacView?

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

What is the FDA product code for LINACwatch, LinacView?

The FDA product code for LINACwatch, LinacView is IYE.

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LINACwatch, LinacView

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: IYE)

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