Clearance Summary
HIPPOCRAT ELECTRONIC STETHOSCOPE, MODEL DR300; SOUNDS EASY AUSCULTATION SOFTWARE received FDA 510(k) clearance under submission number K021087, sponsored by Erecords Limited. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2002-10-11.
- Submission: K021087
- Applicant / Sponsor: Erecords Limited
- Clearance pathway: Abbreviated
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1875
- Decision date: 2002-10-11
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.