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FDA 510(k)

IQM Integral Quality Monitor (also IQM)

K-Number: K162629 · 2016-10-20

ApplicantIrt Systems
Decision Date2016-10-20
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IQM Integral Quality Monitor (also IQM) is a medical device manufactured by Irt Systems. It received FDA 510(k) clearance on 2016-10-20 under approval number K162629. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Irt Systems. The 510(k) number is K162629.

When was IQM Integral Quality Monitor (also IQM) approved by the FDA?

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

What company makes IQM Integral Quality Monitor (also IQM)?

IQM Integral Quality Monitor (also IQM) is manufactured by Irt Systems.

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.

Related Clinical Trials

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Related PubMed Literature

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Official Source

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