FDA 510(k)

C-U2

K-Number: K062897 · 2006-12-14

Decision Date2006-12-14

Product CodeEIA

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

C-U2 is the device name listed in this FDA 510(k) record. The listed applicant is Cefla S.C.R.L.. It received FDA 510(k) clearance on 2006-12-14 under 510(k) number K062897. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the C-U2?

C-U2 is a medical device that received FDA 510(k) clearance on 2006-12-14. The listed applicant is Cefla S.C.R.L.. The 510(k) number is K062897.

When did C-U2 receive FDA 510(k) clearance?

C-U2 received FDA 510(k) clearance on 2006-12-14, under 510(k) number K062897.

Who is the listed applicant for C-U2?

The FDA 510(k) record lists Cefla S.C.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for C-U2?

The FDA product code for C-U2 is EIA.

Other records listing Cefla S.C.R.L. as applicant

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.

K080076RX DC X-RAY UNIT K061114WDS, SIZE 2 AND SIZE 2

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.