Clearance Summary
3 CHANNEL KNEE ELECTRONIC AMPLIFIED STETHOSCOPE received FDA 510(k) clearance under submission number K991756, sponsored by Bio-Research Associates, 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 1999-12-10.
- Submission: K991756
- Applicant / Sponsor: Bio-Research Associates, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1875
- Decision date: 1999-12-10
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.