Sonomed IV, Sonomed V

Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat

Carci Industria E Comercio De Aparelhos Cirurgicos E Orto

The following data is part of a premarket notification filed by Carci Industria E Comercio De Aparelhos Cirurgicos E Orto with the FDA for Sonomed Iv, Sonomed V.

Pre-market Notification Details

Device IDK202788
510k NumberK202788
Device Name:Sonomed IV, Sonomed V
ClassificationUltrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Applicant Carci Industria E Comercio De Aparelhos Cirurgicos E Orto R. Padre Machado, 82 Sao Paulo,  BR 04127
ContactOrlando Orlandi
CorrespondentBruno Milhoci
PR Servicos Regulatorios Administrativos Ltda Rua Alice Aem Saadi, 855/ 2404 Ribeirao Preto,  BR 14096-570
Product CodeIMI  
CFR Regulation Number890.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-22
Decision Date2021-12-23

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