ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable

ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable is an FDA 510(k)-cleared medical device (K192385) manufactured by Ivwatch, LLC. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 1, 2020. Regulation: 8.