Clearance Summary
CARDIAC MINISCOPE & MINIGRAPH received FDA 510(k) clearance under submission number K780297, sponsored by Arco Medical Products Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1978-05-19.
- Submission: K780297
- Applicant / Sponsor: Arco Medical Products Co.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2300
- Decision date: 1978-05-19
Classification & Regulation
This clearance is catalogued under FDA product code DRT and 21 CFR 870.2300, within the Cardiovascular review panel as a Class II device.