510(k) Report

Devices descending from K022121

9 later devices reach PSG Input Box, Model JE-912AK through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120888PSG-1100 Sleep Diagnostic SystemNihon Kohden Corp.201261
+1K062943Polysmith Sleep System, Model NTI5498Neurotronics, Inc.20077—
+1K050833Electrode Junction Box, Model JE-921ANihon Kohden America, Inc.20057—
+2K142774Polysmith Sleep SystemNeurotronics, Inc.20154—
+2K131415Live View Panel (LVP)Neurotronics, Inc.20130—
+3K181709Serenity Piezo Sensor, Serenity Thermocouple SensorNeurotronics, Inc.20180—
+3K173868Serenity Body Position Sensor, Serenity RIP SensorsNeurotronics, Inc.20181—
+3K161650Polysmith Sleep System, Model NTI7593Neurotronics, Inc.20170—
+4K251480PV01 PVDF Effort SensorNeurotronics, LLC20250—