Clearance Summary
Stethee Pro 1, Stethee Pro Software System received FDA 510(k) clearance under submission number K193631, sponsored by M3Dicine Pty , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2020-10-09.
- Submission: K193631
- Applicant / Sponsor: M3Dicine Pty , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1875
- Decision date: 2020-10-09
Classification & Regulation
This clearance is catalogued under FDA product code DQD and 21 CFR 870.1875, within the Cardiovascular review panel as a Class II device.