Clearance Summary
PC ECG 1200W SYSTEM received FDA 510(k) clearance under submission number K080141, sponsored by Norav Medical , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2008-04-25.
- Submission: K080141
- Applicant / Sponsor: Norav Medical , Ltd.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2300
- Decision date: 2008-04-25
Classification & Regulation
This clearance is catalogued under FDA product code MWI and 21 CFR 870.2300, within the Cardiovascular review panel as a Class II device.