FDA 510(k)

065 Zenith, 074 Zenith

K-Number: K171672 · 2017-10-19

Decision Date2017-10-19

Product CodeDQY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

065 Zenith, 074 Zenith is a medical device manufactured by Inneuroco, Inc.. It received FDA 510(k) clearance on 2017-10-19 under approval number K171672. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 065 Zenith, 074 Zenith?

065 Zenith, 074 Zenith is a medical device that received FDA 510(k) clearance on 2017-10-19. It is manufactured by Inneuroco, Inc.. The 510(k) number is K171672.

When was 065 Zenith, 074 Zenith approved by the FDA?

065 Zenith, 074 Zenith received FDA 510(k) clearance on 2017-10-19, under approval number K171672.

What company makes 065 Zenith, 074 Zenith?

065 Zenith, 074 Zenith is manufactured by Inneuroco, Inc..

What is the FDA product code for 065 Zenith, 074 Zenith?

The FDA product code for 065 Zenith, 074 Zenith is DQY.

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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.