FDA 510(k)

IQM Integral Quality Monitor (also IQM)

Número K: K162629 · 2016-10-20

Data da decisão2016-10-20

Código do produtoIYE

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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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