FDA 510(k)

IQM Integral Quality Monitor (also IQM)

K-번호: K162629 · 2016-10-20

결정일2016-10-20

제품 코드IYE

자문 위원회RA

결정Substantially Equivalent

기기 요약

IQM Integral Quality Monitor (also IQM) is the device name listed in this FDA 510(k) record. The listed applicant is Irt Systems. It received FDA 510(k) clearance on 2016-10-20 under 510(k) number K162629. 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 IQM Integral Quality Monitor (also IQM)?

IQM Integral Quality Monitor (also IQM) is a medical device that received FDA 510(k) clearance on 2016-10-20. The listed applicant is Irt Systems. The 510(k) number is K162629.

When did IQM Integral Quality Monitor (also IQM) receive FDA 510(k) clearance?

IQM Integral Quality Monitor (also IQM) received FDA 510(k) clearance on 2016-10-20, under 510(k) number K162629.

Who is the listed applicant for IQM Integral Quality Monitor (also IQM)?

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

What is the FDA product code for IQM Integral Quality Monitor (also IQM)?

The FDA product code for IQM Integral Quality Monitor (also IQM) is IYE.

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IQM Integral Quality Monitor (also IQM)

기기 요약

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관련 임상시험

관련 기기 (코드: IYE)

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