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FDA 510(k)

ZERION ALPHA, ; ZERION BETA

K-Number: K061804 · 2006-10-06

ApplicantEtkon International GmbH
Decision Date2006-10-06
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ZERION ALPHA, ; ZERION BETA is the device name listed in this FDA 510(k) record. The listed applicant is Etkon International GmbH. It received FDA 510(k) clearance on 2006-10-06 under 510(k) number K061804. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZERION ALPHA, ; ZERION BETA?

ZERION ALPHA, ; ZERION BETA is a medical device that received FDA 510(k) clearance on 2006-10-06. The listed applicant is Etkon International GmbH. The 510(k) number is K061804.

When did ZERION ALPHA, ; ZERION BETA receive FDA 510(k) clearance?

ZERION ALPHA, ; ZERION BETA received FDA 510(k) clearance on 2006-10-06, under 510(k) number K061804.

Who is the listed applicant for ZERION ALPHA, ; ZERION BETA?

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

What is the FDA product code for ZERION ALPHA, ; ZERION BETA?

The FDA product code for ZERION ALPHA, ; ZERION BETA is EIH.

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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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