QEVO System
K-Number: K232159 · 2023-09-21
ApplicantCarl Zeiss Meditec, AG
Decision Date2023-09-21
Product CodeGWG
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
QEVO System is a medical device manufactured by Carl Zeiss Meditec, AG. It received FDA 510(k) clearance on 2023-09-21 under approval number K232159. 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?
QEVO System is a medical device that received FDA 510(k) clearance on 2023-09-21. It is manufactured by Carl Zeiss Meditec, AG. The 510(k) number is K232159.
When was QEVO System approved by the FDA?
QEVO System received FDA 510(k) clearance on 2023-09-21, under approval number K232159.
What company makes QEVO System?
QEVO System is manufactured by Carl Zeiss Meditec, AG.
What is the FDA product code for QEVO System?
The FDA product code for QEVO System is GWG.
Other Devices by Carl Zeiss Meditec, AG
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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.