Clearance Summary
MODEL 7600 REGIONAL OXIMETER SYSTEM WITH EQUANOX TECHNOLOGY received FDA 510(k) clearance under submission number K113215, sponsored by Nonin Medical, 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 2012-05-14.
- Submission: K113215
- Applicant / Sponsor: Nonin Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2700
- Decision date: 2012-05-14
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.