Clearance Summary
ECG-1250A SERIES CARDIOFAX S AND ECG-1350A SERIES CARDIOFAX M received FDA 510(k) clearance under submission number K072217, sponsored by Nihon Kohden America, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2007-08-30.
- Submission: K072217
- Applicant / Sponsor: Nihon Kohden America, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2340
- Decision date: 2007-08-30
Classification & Regulation
This clearance is catalogued under FDA product code DPS and 21 CFR 870.2340, within the Cardiovascular review panel as a Class II device.