510(k) Report

Devices descending from K062943

7 later devices reach Polysmith Sleep System, Model NTI5498 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142774Polysmith Sleep SystemNeurotronics, Inc.20154—
+1K131415Live View Panel (LVP)Neurotronics, Inc.20130—
+1K120888PSG-1100 Sleep Diagnostic SystemNihon Kohden Corp.201261
+2K181709Serenity Piezo Sensor, Serenity Thermocouple SensorNeurotronics, Inc.20180—
+2K173868Serenity Body Position Sensor, Serenity RIP SensorsNeurotronics, Inc.20181—
+2K161650Polysmith Sleep System, Model NTI7593Neurotronics, Inc.20170—
+3K251480PV01 PVDF Effort SensorNeurotronics, LLC20250—