Clearance Summary
ORG-9200A received FDA 510(k) clearance under submission number K002068, sponsored by Nihon Kohden America, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2001-02-08.
- Submission: K002068
- Applicant / Sponsor: Nihon Kohden America, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1025
- Decision date: 2001-02-08
Classification & Regulation
This clearance is catalogued under FDA product code DSI and 21 CFR 870.1025, within the Cardiovascular review panel as a Class II device.