510(k) Report

Devices descending from K915494

18 later devices reach Nellcor Stat-Cap Airway CO2 Indicator, Model N-60 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K982969Nonin Pulse Oximeter and Carbon Dioxide Detector, Models 9843, 9845 and 9847Nonin Medical, Inc.19990—
+1K964305Nihon Kohden Olg-100A Pocketcap Pocket CO2 Monitor with AccessoriesNihon Kohden America, Inc.199716—
+2K992455Nihon Kohden Ogs-2001A Pocketcare and AccessoriesNihon Kohden America, Inc.20000—
+2K990063Nihon Kohden TG-901T CO2 Sensor Kit with AccessoriesNihon Kohden America, Inc.199914—
+3K040875Cap-One, Model TG-920PNihon Kohden America, Inc.200413—
+4K083456Nihon Kohden CO2 Sensor Kit, Model TG-970PNihon Kohden America, Inc.20093—
+4K072843YG-125T and YG-135T Nasal AdapterNihon Kohden America, Inc.20070—
+4K050833Electrode Junction Box, Model JE-921ANihon Kohden America, Inc.20057—
+5K243956TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)Nihon Kohden Corporation20250—
+5K122214TG-970P Sensor Kit W/ New Airway Adapter (YG-213T)Nihon Kohden Corp.20131—
+5K120888PSG-1100 Sleep Diagnostic SystemNihon Kohden Corp.201261
+6K161860TG-970P CO2 Sensor KitNihon Kohden Corporation20170—
+6K142774Polysmith Sleep SystemNeurotronics, Inc.20154—
+6K131415Live View Panel (LVP)Neurotronics, Inc.20130—
+7K181709Serenity Piezo Sensor, Serenity Thermocouple SensorNeurotronics, Inc.20180—
+7K173868Serenity Body Position Sensor, Serenity RIP SensorsNeurotronics, Inc.20181—
+7K161650Polysmith Sleep System, Model NTI7593Neurotronics, Inc.20170—
+8K251480PV01 PVDF Effort SensorNeurotronics, LLC20250—