Clearance Summary
ZOLL PD2000 PACEMAKER/ADVISORY DEFIBRILLATOR, MODEL PD2000, ZOLL D2000 ADVISORY DEFIBRILLATOR, MODEL D2000 received FDA 510(k) clearance under submission number K950856, sponsored by Zoll Medical Corp. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1995-12-29.
- Submission: K950856
- Applicant / Sponsor: Zoll Medical Corp
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5550
- Decision date: 1995-12-29
Classification & Regulation
This clearance is catalogued under FDA product code DRO and 21 CFR 870.5550, within the Cardiovascular review panel as a Class II device.