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FDA 510(k)

NACERA Z AND NACERA Z MEDIUM

K-Number: K080195 · 2008-04-28

ApplicantDoceram Medical Ceramics GmbH
Decision Date2008-04-28
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NACERA Z AND NACERA Z MEDIUM is the device name listed in this FDA 510(k) record. The listed applicant is Doceram Medical Ceramics GmbH. It received FDA 510(k) clearance on 2008-04-28 under 510(k) number K080195. 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 NACERA Z AND NACERA Z MEDIUM?

NACERA Z AND NACERA Z MEDIUM is a medical device that received FDA 510(k) clearance on 2008-04-28. The listed applicant is Doceram Medical Ceramics GmbH. The 510(k) number is K080195.

When did NACERA Z AND NACERA Z MEDIUM receive FDA 510(k) clearance?

NACERA Z AND NACERA Z MEDIUM received FDA 510(k) clearance on 2008-04-28, under 510(k) number K080195.

Who is the listed applicant for NACERA Z AND NACERA Z MEDIUM?

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

What is the FDA product code for NACERA Z AND NACERA Z MEDIUM?

The FDA product code for NACERA Z AND NACERA Z MEDIUM 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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