Clearance Summary
MULTIPLE PATIENT RECEIVER, MODEL ORG-9700A received FDA 510(k) clearance under submission number K071058, sponsored by Nihon Kohden America, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2007-06-29.
- Submission: K071058
- Applicant / Sponsor: Nihon Kohden America, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2910
- Decision date: 2007-06-29
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.