Clearance Summary
Sonomed IV, Sonomed V received FDA 510(k) clearance under submission number K202788, sponsored by Carci Industria E Comercio DE Aparelhos Cirurgicos E Orto. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2021-12-23.
- Submission: K202788
- Applicant / Sponsor: Carci Industria E Comercio DE Aparelhos Cirurgicos E Orto
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5300
- Decision date: 2021-12-23
Classification & Regulation
This clearance is catalogued under FDA product code IMI and 21 CFR 890.5300, within the Physical Medicine review panel as a Class II device.