Clearance Summary
LABTRON ELECTROMAX ELECTRONIC STETHOSCOPE MODEL NO. 04-1060 received FDA 510(k) clearance under submission number K961857, sponsored by Graham-Field, 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 1996-07-03.
- Submission: K961857
- Applicant / Sponsor: Graham-Field, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1875
- Decision date: 1996-07-03
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.