Clearance Summary
HyperView Hyperspectral Tissue Oxygenation Measurement System received FDA 510(k) clearance under submission number K161237, sponsored by Hypermed Imaging, 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 2016-12-16.
- Submission: K161237
- Applicant / Sponsor: Hypermed Imaging, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2700
- Decision date: 2016-12-16
Classification & Regulation
This clearance is catalogued under FDA product code MUD and 21 CFR 870.2700, within the Cardiovascular review panel as a Class II device.