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FDA 510(k)

CLARUS

K-Number: K181444 · 2019-01-10

ApplicantCarl Zeiss Meditec, Inc.
Decision Date2019-01-10
Product CodeQER
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CLARUS is a medical device manufactured by Carl Zeiss Meditec, Inc.. It received FDA 510(k) clearance on 2019-01-10 under approval number K181444. The device is classified under product code QER. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLARUS?

CLARUS is a medical device that received FDA 510(k) clearance on 2019-01-10. It is manufactured by Carl Zeiss Meditec, Inc.. The 510(k) number is K181444.

When was CLARUS approved by the FDA?

CLARUS received FDA 510(k) clearance on 2019-01-10, under approval number K181444.

What company makes CLARUS?

CLARUS is manufactured by Carl Zeiss Meditec, Inc..

What is the FDA product code for CLARUS?

The FDA product code for CLARUS is QER.

Other Devices by Carl Zeiss Meditec, Inc.

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Related Devices (Code: QER)

K191194CLARUSCarl Zeiss Meditec, Inc. K243878CLARUS (700)Carl Zeiss Meditec, Inc.

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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