FDA 510(k)

CardioConfirm

K-Number: K161465 · 2016-09-03

Decision Date2016-09-03

Product CodeDQK

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

CardioConfirm is a medical device manufactured by Mortara Instrument, Inc.. It received FDA 510(k) clearance on 2016-09-03 under approval number K161465. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CardioConfirm?

CardioConfirm is a medical device that received FDA 510(k) clearance on 2016-09-03. It is manufactured by Mortara Instrument, Inc.. The 510(k) number is K161465.

When was CardioConfirm approved by the FDA?

CardioConfirm received FDA 510(k) clearance on 2016-09-03, under approval number K161465.

What company makes CardioConfirm?

CardioConfirm is manufactured by Mortara Instrument, Inc..

What is the FDA product code for CardioConfirm?

The FDA product code for CardioConfirm is DQK.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.