510(k) Report

Devices descending from K153605

4 later devices reach ivWatch Model 400 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162478ivWatchIvwatch, LLC20163—
+2K222212ivWatch Model 400Ivwatch, LLC20220—
+2K192385ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient CableIvwatch, LLC20201—
+3K233881ivWatch® Model 400Ivwatch, LLC20240—