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.
| Device ID | K202788 |
| 510k Number | K202788 |
| Device Name: | Sonomed IV, Sonomed V |
| Classification | Ultrasonic 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 |
| Contact | Orlando Orlandi |
| Correspondent | Bruno Milhoci PR Servicos Regulatorios Administrativos Ltda Rua Alice Aem Saadi, 855/ 2404 Ribeirao Preto, BR 14096-570 |
| Product Code | IMI |
| CFR Regulation Number | 890.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-22 |
| Decision Date | 2021-12-23 |