510(k) Report

Devices descending from K162478

3 later devices reach ivWatch through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222212ivWatch Model 400Ivwatch, LLC20220—
+1K192385ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient CableIvwatch, LLC20201—
+2K233881ivWatch® Model 400Ivwatch, LLC20240—