Clearance Summary
Nihon Kohden Afib Detection Program QP-039P received FDA 510(k) clearance under submission number K152305, sponsored by Nihon Kohden Corporation. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2016-04-08.
- Submission: K152305
- Applicant / Sponsor: Nihon Kohden Corporation
- Clearance pathway: Abbreviated
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1025
- Decision date: 2016-04-08
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.