Clearance Summary
North-vision Multi-parameter Patient Monitor received FDA 510(k) clearance under submission number K173036, sponsored by North-Vision Tech., 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 2018-12-21.
- Submission: K173036
- Applicant / Sponsor: North-Vision Tech., Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1025
- Decision date: 2018-12-21
Classification & Regulation
This clearance is catalogued under FDA product code MHX and 21 CFR 870.1025, within the Cardiovascular review panel as a Class II device.