510(k) K131585

INTEL-GE CARE INNOVATIONS QUIETCARE by Intel-Ge Care Innovations, LLC — Product Code KMI

K131585 is an FDA 510(k) premarket notification submitted by Intel-Ge Care Innovations, LLC for the device "INTEL-GE CARE INNOVATIONS QUIETCARE". The FDA issued a decision of Substantially Equivalent on October 8, 2013. The device falls under product code KMI (Monitor, Bed Patient), a Class I device regulated under 21 CFR 880.2400. Intel-Ge Care Innovations, LLC has at least 2 other 510(k) clearances on record.