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FDA 510(k)

QEVO System with KINEVO 900

K-Number: K170667 · 2017-08-18

Decision Date2017-08-18
Product CodeGWG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

QEVO System with KINEVO 900 is a medical device manufactured by Carl Zeiss Meditec, AG. It received FDA 510(k) clearance on 2017-08-18 under approval number K170667. The device is classified under product code GWG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QEVO System with KINEVO 900?

QEVO System with KINEVO 900 is a medical device that received FDA 510(k) clearance on 2017-08-18. It is manufactured by Carl Zeiss Meditec, AG. The 510(k) number is K170667.

When was QEVO System with KINEVO 900 approved by the FDA?

QEVO System with KINEVO 900 received FDA 510(k) clearance on 2017-08-18, under approval number K170667.

What company makes QEVO System with KINEVO 900?

QEVO System with KINEVO 900 is manufactured by Carl Zeiss Meditec, AG.

What is the FDA product code for QEVO System with KINEVO 900?

The FDA product code for QEVO System with KINEVO 900 is GWG.

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Official Source

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