FDA 510(k) Applications Submitted by NIHON KOHDEN AMERICA, INC.

FDA 510(k) Number Submission Date Device Name Applicant
K000338 02/03/2000 VITAPORT 3 NIHON KOHDEN AMERICA, INC.
K000517 02/16/2000 LIFE SCOPE EC, MODEL BSM-1102 NIHON KOHDEN AMERICA, INC.
K010590 02/27/2001 NEUROPACK MICRO, MODEL MED-9100A SERIES NIHON KOHDEN AMERICA, INC.
K011204 04/19/2001 NEUROFAX, MODELS EEG-1100A, EEG-9100A NIHON KOHDEN AMERICA, INC.
K001433 05/08/2000 CNS-9300 SERIES CENTRAL STATION NIHON KOHDEN AMERICA, INC.
K001693 06/02/2000 LIFE SCOPE P, MODEL BSM-4100 SERIES NIHON KOHDEN AMERICA, INC.
K991899 06/04/1999 NIHON KOHDEN MEB-2200A NEUROPACK EVOKED POTENTIAL & EMG MEASURING SYSTEM WITH ACCESSORIES NIHON KOHDEN AMERICA, INC.
K011918 06/20/2001 NIHON KOHDEN BSM-2300A SERIES BEDSIDE MONITOR AND ACCESSORIES, MODEL BSM-2300A SERIES NIHON KOHDEN AMERICA, INC.
K002068 07/07/2000 ORG-9200A NIHON KOHDEN AMERICA, INC.
K992455 07/23/1999 NIHON KOHDEN OGS-2001A POCKETCARE AND ACCESSORIES NIHON KOHDEN AMERICA, INC.
K002473 08/11/2000 WEC-7101A POCKET SIZE ECG MONITOR AND ACCESSORIES NIHON KOHDEN AMERICA, INC.
K992742 08/16/1999 NEUROFAX, MODEL EEG-1100A NIHON KOHDEN AMERICA, INC.
K990031 01/05/1999 NIHON KOHDEN ECG-9010K AND ECG-9020K CARDIOFAX GEM AND ACCESSORIES NIHON KOHDEN AMERICA, INC.
K990063 01/08/1999 NIHON KOHDEN TG-901T CO2 SENSOR KIT WITH ACCESSORIES NIHON KOHDEN AMERICA, INC.
K971194 04/01/1997 NIHON KOHDEN TEC-6100A CARDIOLIFE MINI DEFIBRILLATOR & ACCESSORIES NIHON KOHDEN AMERICA, INC.
K961272 04/02/1996 NIHON KOHDEN ECG-9320A CARDIOFAX AND ACCESSORIES NIHON KOHDEN AMERICA, INC.
K971355 04/11/1997 NIHON KOHDEN TEC-7531 CARDIOLIFE PORTABLE DEFIBRILLATOR AND ACCESSORIES NIHON KOHDEN AMERICA, INC.
K971436 04/18/1997 NIHON KOHDEN TEC-7511A/TEC-7521A CARDIOLIFE PORTABLE DEFIBRILLATOR AND ACCESSORIES NIHON KOHDEN AMERICA, INC.
K972310 06/20/1997 NIHON KOHDEN QP-932E ECG EXERCISE TEST OPTION FOR THE NIHON KOHDEN ECG-9320/A CARDIOFAX ELECTROCARDIOGRAPH NIHON KOHDEN AMERICA, INC.
K983072 09/02/1998 AMBULATORY EEG/SLEEP RECORDER AND ACCESSORIES, MODEL # SSR3201 NIHON KOHDEN AMERICA, INC.
K973918 10/15/1997 NIHON KOHDEN BSM-1101 AND BSM-1102 PATIENT MONITOR AND ACCESSORIES NIHON KOHDEN AMERICA, INC.
K964305 10/29/1996 NIHON KOHDEN OLG-100A POCKETCAP POCKET CO2 MONITOR WITH ACCESSORIES NIHON KOHDEN AMERICA, INC.
K974292 11/14/1997 NIHON KOHDEN TL-101T, TL-120T AND TL-121T SPO2 PROBES AND ACCESSORIES NIHON KOHDEN AMERICA, INC.
K984504 12/18/1998 NIHON KOHDEN ECG-9110K AND ECG-9130K CARDIOFAX Q AND ACCESSORIES NIHON KOHDEN AMERICA, INC.
K080342 02/08/2008 NIHON KOHDEN BEDSIDE MONITOR, MODEL BSM-6000S SERIES NIHON KOHDEN AMERICA, INC.
K080546 02/28/2008 NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200A NIHON KOHDEN AMERICA, INC.
K071969 07/17/2007 SEN-4100 ELECTRIC STIMULATOR NIHON KOHDEN AMERICA, INC.
K072060 07/27/2007 QP-156E ECG EXERCISE TEST OPTION FOR THE ECG-1500A SERIES/CARDIOFAX V NIHON KOHDEN AMERICA, INC.
K072217 08/09/2007 ECG-1250A SERIES CARDIOFAX S AND ECG-1350A SERIES CARDIOFAX M NIHON KOHDEN AMERICA, INC.
K082785 09/23/2008 NIHON KOHDEN BEDSIDE MONITOR, BSM 9100A SERIES NIHON KOHDEN AMERICA, INC.
K072843 10/04/2007 YG-125T AND YG-135T NASAL ADAPTER NIHON KOHDEN AMERICA, INC.
K083271 11/06/2008 BSM-2300 &BSM6000 WITH CGS-9001 SERIES COMMUNICATION GATEWAY, MODEL CGS-9001 SERIES OPTIONAL ACCESSORY NIHON KOHDEN AMERICA, INC.
K083456 11/21/2008 NIHON KOHDEN CO2 SENSOR KIT, MODEL TG-970P NIHON KOHDEN AMERICA, INC.
K073491 12/12/2007 EEG-1100A SWITCH BOX NIHON KOHDEN AMERICA, INC.
K073550 12/18/2007 PREFENSE EDNS-9000 SERIES NURSE CENTRAL STATION NIHON KOHDEN AMERICA, INC.
K020046 01/07/2002 MULTIGAS UNIT, MODEL AG-920RA NIHON KOHDEN AMERICA, INC.
K030105 01/13/2003 ANESTHESIA MONITOR; BEDSIDE MONITOR, SERIES BSM-5130A NIHON KOHDEN AMERICA, INC.
K040395 02/17/2004 CENTRAL TELEMETRY SYSTEM, MODEL WEP-4200A SERIES NIHON KOHDEN AMERICA, INC.
K050833 04/01/2005 ELECTRODE JUNCTION BOX, MODEL JE-921A NIHON KOHDEN AMERICA, INC.
K040875 04/02/2004 CAP-ONE, MODEL TG-920P NIHON KOHDEN AMERICA, INC.
K071058 04/16/2007 MULTIPLE PATIENT RECEIVER, MODEL ORG-9700A NIHON KOHDEN AMERICA, INC.
K051178 05/09/2005 MEE-1000A NEUROMASTER NIHON KOHDEN AMERICA, INC.
K022121 07/01/2002 PSG INPUT BOX, MODEL JE-912AK NIHON KOHDEN AMERICA, INC.
K062115 07/24/2006 CARBON DIOXIDE MONITOR, MODEL OLG-2800A NIHON KOHDEN AMERICA, INC.
K032749 09/05/2003 BEDSIDE MONITOR, MODEL OPV-1500 NIHON KOHDEN AMERICA, INC.
K052511 09/14/2005 CARDIOFAX CE, MODEL ECG-1500 A NIHON KOHDEN AMERICA, INC.
K042827 10/12/2004 CARDIOFAX CE, MODEL PEA-1110K NIHON KOHDEN AMERICA, INC.
K023475 10/16/2002 CNS-9700 SERIES CENTRAL NURSE STATION AND ACCESSORIES NIHON KOHDEN AMERICA, INC.
K033475 11/03/2003 WIRELESS INPUT UNIT, MODEL WEE-1000A SERIES NIHON KOHDEN AMERICA, INC.
K043517 12/20/2004 TRANSMITTER, ZS-940PA SERIES NIHON KOHDEN AMERICA, INC.
K120485 02/17/2012 NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND AND FFT P NIHON KOHDEN AMERICA, INC.
K092573 08/20/2009 NIHON KOHDEN QP-160AK EEG TREND PROGRAM NIHON KOHDEN AMERICA, INC.
K113117 10/21/2011 NIHON KOHDEN EEG-1200A WITH JE-120A MULTI CHANNEL ELECTRODE JUNCTION BOX NIHON KOHDEN AMERICA, INC.


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