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FDA 510(k)

CLARUJUST

K-Number: K092089 · 2010-03-10

ApplicantAudigence, Inc.
Decision Date2010-03-10
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

CLARUJUST is the device name listed in this FDA 510(k) record. The listed applicant is Audigence, Inc.. It received FDA 510(k) clearance on 2010-03-10 under 510(k) number K092089. The device is classified under product code EWO. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLARUJUST?

CLARUJUST is a medical device that received FDA 510(k) clearance on 2010-03-10. The listed applicant is Audigence, Inc.. The 510(k) number is K092089.

When did CLARUJUST receive FDA 510(k) clearance?

CLARUJUST received FDA 510(k) clearance on 2010-03-10, under 510(k) number K092089.

Who is the listed applicant for CLARUJUST?

The FDA 510(k) record lists Audigence, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLARUJUST?

The FDA product code for CLARUJUST is EWO.

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Related Devices (Code: EWO)

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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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