
Intel-Ge Care Innovations, LLC
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MODIFICATION TO INTEL-GE CARE IINOVATIONS GUIDE is an FDA 510(k)-cleared medical device (K130290) manufactured by Intel-Ge Care Innovations, LLC. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 3, 2013. Regulation: 8.