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FDA 510(k)

CERAMILL ZI

K-Number: K063511 · 2007-02-02

ApplicantAmann Girrbach America, Inc.
Decision Date2007-02-02
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CERAMILL ZI is the device name listed in this FDA 510(k) record. The listed applicant is Amann Girrbach America, Inc.. It received FDA 510(k) clearance on 2007-02-02 under 510(k) number K063511. 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 CERAMILL ZI?

CERAMILL ZI is a medical device that received FDA 510(k) clearance on 2007-02-02. The listed applicant is Amann Girrbach America, Inc.. The 510(k) number is K063511.

When did CERAMILL ZI receive FDA 510(k) clearance?

CERAMILL ZI received FDA 510(k) clearance on 2007-02-02, under 510(k) number K063511.

Who is the listed applicant for CERAMILL ZI?

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

What is the FDA product code for CERAMILL ZI?

The FDA product code for CERAMILL ZI is EIH.

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Related Devices (Code: EIH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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