Clearance Summary
Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth received FDA 510(k) clearance under submission number K182196, sponsored by Imediplus, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2018-09-11.
- Submission: K182196
- Applicant / Sponsor: Imediplus, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1875
- Decision date: 2018-09-11
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.