Clearance Summary
CARDIOPHONE received FDA 510(k) clearance under submission number K781973, sponsored by North American Motronic. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1979-03-21.
- Submission: K781973
- Applicant / Sponsor: North American Motronic
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class III
- Regulation citation: 21 CFR 870.3610
- Decision date: 1979-03-21
Classification & Regulation
This clearance is catalogued under FDA product code DXY and 21 CFR 870.3610, within the Cardiovascular review panel as a Class III device.