Clearance Summary
SALTZMAN STETHOSCOPE HEAD received FDA 510(k) clearance under submission number K854771, sponsored by K & S Medicorp. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1986-05-09.
- Submission: K854771
- Applicant / Sponsor: K & S Medicorp
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class I
- Regulation citation: 21 CFR 870.1875
- Decision date: 1986-05-09
Classification & Regulation
This clearance is catalogued under FDA product code LDE and 21 CFR 870.1875, within the Cardiovascular review panel as a Class I device.