Clearance Summary
SPRAGUE RAPPAPORT/SH-6008 DISPOS. STETH received FDA 510(k) clearance under submission number K843324, sponsored by Cher Mel Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1985-06-06.
- Submission: K843324
- Applicant / Sponsor: Cher Mel Corp.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class I
- Regulation citation: 21 CFR 870.1875
- Decision date: 1985-06-06
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.