510(k) Report

Devices descending from K142774

4 later devices reach Polysmith Sleep System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181709Serenity Piezo Sensor, Serenity Thermocouple SensorNeurotronics, Inc.20180—
+1K173868Serenity Body Position Sensor, Serenity RIP SensorsNeurotronics, Inc.20181—
+1K161650Polysmith Sleep System, Model NTI7593Neurotronics, Inc.20170—
+2K251480PV01 PVDF Effort SensorNeurotronics, LLC20250—