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FDA 510(k)

CERAVITAL MIDDLE EAR IMPLANT

K-Number: K913619 · 1991-10-15

ApplicantFriedrichsfeld Medizintechnik AG
Decision Date1991-10-15
Product CodeETB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

CERAVITAL MIDDLE EAR IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Friedrichsfeld Medizintechnik AG. It received FDA 510(k) clearance on 1991-10-15 under 510(k) number K913619. The device is classified under product code ETB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CERAVITAL MIDDLE EAR IMPLANT?

CERAVITAL MIDDLE EAR IMPLANT is a medical device that received FDA 510(k) clearance on 1991-10-15. The listed applicant is Friedrichsfeld Medizintechnik AG. The 510(k) number is K913619.

When did CERAVITAL MIDDLE EAR IMPLANT receive FDA 510(k) clearance?

CERAVITAL MIDDLE EAR IMPLANT received FDA 510(k) clearance on 1991-10-15, under 510(k) number K913619.

Who is the listed applicant for CERAVITAL MIDDLE EAR IMPLANT?

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

What is the FDA product code for CERAVITAL MIDDLE EAR IMPLANT?

The FDA product code for CERAVITAL MIDDLE EAR IMPLANT is ETB.

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Related Devices (Code: ETB)

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

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