Clearance Summary
3160 MRI PATIENT MONITORING SYSTEM received FDA 510(k) clearance under submission number K053462, sponsored by Invivo Corporation. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2006-01-18.
- Submission: K053462
- Applicant / Sponsor: Invivo Corporation
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2300
- Decision date: 2006-01-18
Classification & Regulation
This clearance is catalogued under FDA product code MWI and 21 CFR 870.2300, within the Cardiovascular review panel as a Class II device.