Clearance Summary
ZOLL EPCR IOS received FDA 510(k) clearance under submission number K131919, sponsored by ZOLL Medical Corporation. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2013-12-17.
- Submission: K131919
- Applicant / Sponsor: ZOLL Medical Corporation
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2450
- Decision date: 2013-12-17
Classification & Regulation
This clearance is catalogued under FDA product code DXJ and 21 CFR 870.2450, within the Cardiovascular review panel as a Class II device.