Clearance Summary
NIHON KHDEN PREFENSE EDNS-9000 SERIES CENTRAL NURSE STATION received FDA 510(k) clearance under submission number K102106, sponsored by Nihon Kohden 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 2010-12-17.
- Submission: K102106
- Applicant / Sponsor: Nihon Kohden Corp.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2910
- Decision date: 2010-12-17
Classification & Regulation
This clearance is catalogued under FDA product code DRG and 21 CFR 870.2910, within the Cardiovascular review panel as a Class II device.