Clearance Summary
Nihon Kohden NKV-550 Series Ventilator System received FDA 510(k) clearance under submission number K192307, sponsored by Nihon Kohden Orangemed, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2020-01-10.
- Submission: K192307
- Applicant / Sponsor: Nihon Kohden Orangemed, Inc.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5895
- Decision date: 2020-01-10
Classification & Regulation
This clearance is catalogued under FDA product code CBK and 21 CFR 868.5895, within the Anesthesiology review panel as a Class II device.