FDA 510(k)

CediTEC

K-Number: K220743 · 2022-07-05

Decision Date2022-07-05

Product CodeEBI

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

CediTEC is the device name listed in this FDA 510(k) record. The listed applicant is Voco GmbH. It received FDA 510(k) clearance on 2022-07-05 under 510(k) number K220743. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CediTEC?

CediTEC is a medical device that received FDA 510(k) clearance on 2022-07-05. The listed applicant is Voco GmbH. The 510(k) number is K220743.

When did CediTEC receive FDA 510(k) clearance?

CediTEC received FDA 510(k) clearance on 2022-07-05, under 510(k) number K220743.

Who is the listed applicant for CediTEC?

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

What is the FDA product code for CediTEC?

The FDA product code for CediTEC is EBI.

Other records listing Voco GmbH as applicant

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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.