Clearance Summary
MySOZO Software version 6.1.0.1 (SW version 6.1.0.1) received FDA 510(k) clearance under submission number K260224, sponsored by ImpediMed Limited. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2026-08-17.
- Submission: K260224
- Applicant / Sponsor: ImpediMed Limited
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2770
- Decision date: 2026-08-17
Classification & Regulation
This clearance is catalogued under FDA product code DSB and 21 CFR 870.2770, within the Cardiovascular review panel as a Class II device.