510(k) Report

Devices descending from K142374

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153605ivWatch Model 400Ivwatch, LLC20164—
+2K162478ivWatchIvwatch, LLC20163—
+3K222212ivWatch Model 400Ivwatch, LLC20220—
+3K192385ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient CableIvwatch, LLC20201—
+4K233881ivWatch® Model 400Ivwatch, LLC20240—