Clearance Summary
SONOPULSE COMPACT 1MHZ, SONOPULSE COMPACT 3MHZ received FDA 510(k) clearance under submission number K131309, sponsored by Ibramed Equipamentos Medicos. 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 2014-01-27.
- Submission: K131309
- Applicant / Sponsor: Ibramed Equipamentos Medicos
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5300
- Decision date: 2014-01-27
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.