Clearance Summary
MODIFICATION TO INTEL-GE CARE IINOVATIONS GUIDE received FDA 510(k) clearance under submission number K130290, sponsored by Intel-Ge Care Innovations, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2013-06-04.
- Submission: K130290
- Applicant / Sponsor: Intel-Ge Care Innovations, LLC
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2910
- Decision date: 2013-06-04
Classification & Regulation
This clearance is catalogued under FDA product code DRG and 21 CFR 870.2910, within the Cardiovascular review panel as a Class II device.