Clearance Summary
EMS-XL CARDIAC ELECTROPHYSIOLOGY SYSTEM received FDA 510(k) clearance under submission number K071348, sponsored by Mennen Medical , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2007-09-07.
- Submission: K071348
- Applicant / Sponsor: Mennen Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1425
- Decision date: 2007-09-07
Classification & Regulation
This clearance is catalogued under FDA product code DQK and 21 CFR 870.1425, within the Cardiovascular review panel as a Class II device.