Clearance Summary
SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION received FDA 510(k) clearance under submission number K131044, sponsored by Diacoustic Medical Devices (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 2013-09-04.
- Submission: K131044
- Applicant / Sponsor: Diacoustic Medical Devices (Pty) , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1875
- Decision date: 2013-09-04
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.