Clearance Summary
INTEL-GE CARE INNOVATIONS QUIETCARE received FDA 510(k) clearance under submission number K131585, sponsored by Intel-Ge Care Innovations, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2013-10-08.
- Submission: K131585
- Applicant / Sponsor: Intel-Ge Care Innovations, LLC
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.2400
- Decision date: 2013-10-08
Classification & Regulation
This clearance is catalogued under FDA product code KMI and 21 CFR 880.2400, within the General Hospital review panel as a Class I device.