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FDA 510(k)

COMPOTHIXO

K-Number: K111465 · 2012-07-25

ApplicantKerrhawe SA
Decision Date2012-07-25
Product CodeDZN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

COMPOTHIXO is the device name listed in this FDA 510(k) record. The listed applicant is Kerrhawe SA. It received FDA 510(k) clearance on 2012-07-25 under 510(k) number K111465. The device is classified under product code DZN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMPOTHIXO?

COMPOTHIXO is a medical device that received FDA 510(k) clearance on 2012-07-25. The listed applicant is Kerrhawe SA. The 510(k) number is K111465.

When did COMPOTHIXO receive FDA 510(k) clearance?

COMPOTHIXO received FDA 510(k) clearance on 2012-07-25, under 510(k) number K111465.

Who is the listed applicant for COMPOTHIXO?

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

What is the FDA product code for COMPOTHIXO?

The FDA product code for COMPOTHIXO is DZN.

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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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