FDA 510(k)

Sonomed IV, Sonomed V

Numéro K : K202788 · 2021-12-23

DemandeurCarci Industria E Comercio DE Aparelhos Cirurgicos E Orto

Date de décision2021-12-23

Code produitIMI

Comité consultatifPM

DécisionSubstantially Equivalent

Résumé du dispositif

Sonomed IV, Sonomed V is the device name listed in this FDA 510(k) record. The listed applicant is Carci Industria E Comercio DE Aparelhos Cirurgicos E Orto. It received FDA 510(k) clearance on 2021-12-23 under 510(k) number K202788. The device is classified under product code IMI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Sonomed IV, Sonomed V?

Sonomed IV, Sonomed V is a medical device that received FDA 510(k) clearance on 2021-12-23. The listed applicant is Carci Industria E Comercio DE Aparelhos Cirurgicos E Orto. The 510(k) number is K202788.

When did Sonomed IV, Sonomed V receive FDA 510(k) clearance?

Sonomed IV, Sonomed V received FDA 510(k) clearance on 2021-12-23, under 510(k) number K202788.

Who is the listed applicant for Sonomed IV, Sonomed V?

The FDA 510(k) record lists Carci Industria E Comercio DE Aparelhos Cirurgicos E Orto as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sonomed IV, Sonomed V?

The FDA product code for Sonomed IV, Sonomed V is IMI.

Essais cliniques associés

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Dispositifs connexes (Code : IMI)

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Source officielle

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