510(k) Report

Devices descending from K002068

17 later devices reach ORG-9200A through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071058Multiple Patient Receiver, Model Org-9700ANihon Kohden America, Inc.2007161
+2K110809Wireless Monitoring SystemCarefusion 303, Inc.20112—
+2K102106Nihon Khden Prefense Edns-9000 Series Central Nurse StationNihon Kohden Corp.20100—
+2K080342Nihon Kohden Bedside Monitor, Model BSM-6000S SeriesNihon Kohden America, Inc.200811—
+3K201949Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM…Nihon Kohden Corporation20213—
+3K163459Nihon Kohden Vital Sign TelemeterNihon Kohden Corporation20170—
+3K153707Nihon Kohden Vital Sign TelemeterNihon Kohden Corporation20161—
+3K132447Vitalconnect Platform by Vital Connect Inc.Vitalconnect, Inc.20141—
+3K083271BSM-2300 &BSM6000 with CGS-9001 Series Communication Gateway, Model CGS-9001 Series…Nihon Kohden America, Inc.20082—
+3K082785Nihon Kohden Bedside Monitor, BSM 9100A SeriesNihon Kohden America, Inc.20085—
+4K213316Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000…Nihon Kohden Corporation20211—
+4K203435Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 Bedside…Nihon Kohden Corporation20210—
+4K191870VV330 Continuous ECG Platform, VivaLNK Adhesive PatchVivaLNK, Inc.20200—
+4K151080Nihon Kohden CSM 1901 Bedside MonitorNihon Kohden201541
+4K112637Netkonnect Remote Network ExtensionNihon Kohden20111—
+5K220989Next Generation NetKonnectNihon Kohden Digital Health Solutions, Inc.20220—
+5K220976Life Scope PT BSM-1700 Series Bedside MonitorNihon Kohden Corporation20220—