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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Carl Zeiss Meditec, AG. It received FDA 510(k) clearance on 2023-09-21 under 510(k) 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. The listed applicant is Carl Zeiss Meditec, AG. The 510(k) number is K232159.

When did QEVO System receive FDA 510(k) clearance?

QEVO System received FDA 510(k) clearance on 2023-09-21, under 510(k) number K232159.

Who is the listed applicant for QEVO System?

The FDA 510(k) record lists Carl Zeiss Meditec, AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QEVO System?

The FDA product code for QEVO System is GWG.

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Related Devices (Code: GWG)

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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.

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