FDA 510(k)

Therapy EC, Therapy XT

Numéro K : K232813 · 2024-12-19

DemandeurDmc Importacao E Exportacao DE Equipamentos Ltda

Date de décision2024-12-19

Code produitNHN

Comité consultatifPM

DécisionSubstantially Equivalent

Résumé du dispositif

Therapy EC, Therapy XT is the device name listed in this FDA 510(k) record. The listed applicant is Dmc Importacao E Exportacao DE Equipamentos Ltda. It received FDA 510(k) clearance on 2024-12-19 under 510(k) number K232813. The device is classified under product code NHN. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Therapy EC, Therapy XT?

Therapy EC, Therapy XT is a medical device that received FDA 510(k) clearance on 2024-12-19. The listed applicant is Dmc Importacao E Exportacao DE Equipamentos Ltda. The 510(k) number is K232813.

When did Therapy EC, Therapy XT receive FDA 510(k) clearance?

Therapy EC, Therapy XT received FDA 510(k) clearance on 2024-12-19, under 510(k) number K232813.

Who is the listed applicant for Therapy EC, Therapy XT?

The FDA 510(k) record lists Dmc Importacao E Exportacao DE Equipamentos Ltda as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Therapy EC, Therapy XT?

The FDA product code for Therapy EC, Therapy XT is NHN.

Essais cliniques associés

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Dispositifs connexes (Code : NHN)

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Source officielle

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