FDA 510(k) Applications Submitted by Omron Healthcare, Inc.

FDA 510(k) Number Submission Date Device Name Applicant
K060766 03/22/2006 PORTABLE, ELECTROCARDIOGRAPH (ECG) MONITOR, MODEL HCG-801 OMRON HEALTHCARE, INC.
K061822 06/28/2006 OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH COMFIT CUFF, MODEL HEM 780 N3 OMRON HEALTHCARE, INC.
K062043 07/19/2006 BODY COMPOSITION MONITOR WITH SCALE, MODEL HBF-500 OMRON HEALTHCARE, INC.
K963575 09/06/1996 HBF-1000 OMRON BODY COMPOSITION ANALYZER OMRON HEALTHCARE, INC.
K051233 05/13/2005 OMRON MODEL 514N TYMPANIC THERMOMETER OMRON HEALTHCARE, INC.
K021682 05/22/2002 OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODELS HEM-773, HEM-773AC OMRON HEALTHCARE, INC.
K032305 07/25/2003 OMRON INTELLISENSE DIGITAL BLOOD PRESSURE MONITOR, MODEL HEM-907XL OMRON HEALTHCARE, INC.
K052153 08/09/2005 OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-741CREL OMRON HEALTHCARE, INC.
K052154 08/09/2005 OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-711AC OMRON HEALTHCARE, INC.
K042505 09/15/2004 OMRON DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL HEM-609N OMRON HEALTHCARE, INC.
K042506 09/15/2004 OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-780M OMRON HEALTHCARE, INC.
K050233 02/01/2005 OMRON NON-INVASIVE BLOOD PRESSURE MONITOR WITH AUGMENTATION INDEX, MODEL HEM-9000AI OMRON HEALTHCARE, INC.
K043018 11/02/2004 OMRON DIGITAL BLOOD PRESSURE MONITOR, MODEL HEM-906 OMRON HEALTHCARE, INC.
K043060 11/05/2004 OMRON FAT LOSS MONITOR WITH SCALE, MODEL HBF-400 OMRON HEALTHCARE, INC.
K011652 05/29/2001 BODY FAT ANALYZER, MODEL HBF-306 OMRON HEALTHCARE, INC.
K001671 06/01/2000 ULTRA COMPACT WRIST BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODEL HEM-630 OMRON HEALTHCARE, INC.
K001670 06/01/2000 AUTOMATIC BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODEL HEM-757 OMRON HEALTHCARE, INC.
K001848 06/19/2000 OMRON INTELLISENSE BLOOD PRESSURE MONITOR, MODEL HEM-907 OMRON HEALTHCARE, INC.
K110068 01/10/2011 MODEL PM3030 OMRON HEALTHCARE, INC.
K080289 02/04/2008 1500 PRO OMRON HEALTHCARE, INC.
K120516 02/21/2012 LONG LIFE PADTM OMRON HEALTHCARE, INC.
K110501 02/22/2011 HEM-4030 OMRON HEALTHCARE, INC.
K060811 03/24/2006 OMRON COMPRESSOR SYSTEMS, MODELS NE-C28,NE-C30 OMRON HEALTHCARE, INC.
K110860 03/29/2011 COMP A-I-R OMRON HEALTHCARE, INC.
K141140 05/02/2014 COMP A-I-R OMRON HEALTHCARE, INC.
K091676 06/09/2009 MC-245, MC-246, MC-247, MC-341, MC-343, MC-344 OMRON HEALTHCARE, INC.
K081654 06/12/2008 HEM-9000AI OMRON HEALTHCARE, INC.
K131742 06/13/2013 HEM-6131 OMRON HEALTHCARE, INC.
K131749 06/14/2013 HEM-6221 OMRON HEALTHCARE, INC.
K071645 06/15/2007 MODEL HBP T-105 SERIES, MODEL T-105 AND T-105S OMRON HEALTHCARE, INC.
K121932 07/02/2012 HEM-7200-Z (BP742) OMRON HEALTHCARE, INC.
K141978 07/21/2014 MAXPOWER RELIEF OMRON HEALTHCARE, INC.
K082812 09/24/2008 OMRON MODEL HBP-2070 VITAL SIGNS MONITOR OMRON HEALTHCARE, INC.
K113185 10/28/2011 MODEL HBP-1300 OMRON HEALTHCARE, INC.
K133379 11/04/2013 HEM-7311 OMRON HEALTHCARE, INC.
K133383 11/04/2013 HEM-7320 OMRON HEALTHCARE, INC.
K123498 11/13/2012 BP652N (HEM-6300-Z) OMRON HEALTHCARE, INC.
K062263 08/04/2006 OMRON MICRO-AIR VIBRATING MESH NEBULIZER, MODEL NE-U22 OMRON HEALTHCARE, INC.
K063690 12/12/2006 COLIN PRESS MATE, MODEL BP S510 OMRON HEALTHCARE, INC.
K160115 01/19/2016 Heat Pain Pro OMRON HEALTHCARE, INC.
K190693 03/18/2019 HEM-6410T-ZL Wrist Blood Pressure Monitor Omron Healthcare, Inc.
K172079 07/10/2017 Avail Omron Healthcare, Inc.
K181992 07/26/2018 Heat Pain Pro Omron Healthcare, Inc.
K162092 07/28/2016 Evolv Model BP7000 Upper Arm Blood Pressure Monitor OMRON HEALTHCARE, INC.
K182120 08/06/2018 Maxpower Relief Omron Healthcare, Inc.
K182127 08/06/2018 Wrist Blood Pressure Monitor Model BP6100 Omron Healthcare, Inc.
K202228 08/07/2020 Omron Model BP7900 Blood Pressure Monitor + EKG Omron Healthcare, Inc.
K182166 08/10/2018 Wrist Blood Pressure Monitor Model BP4350 Omron Healthcare, Inc.
K182481 09/10/2018 HEM-6410T-ZM Wrist Blood Pressure Monitor Omron Healthcare, Inc.
K182579 09/19/2018 Omron Model BP7900 Blood Pressure Monitor + EKG Omron Healthcare, Inc.
K163045 10/31/2016 Omron HEM-6400T-Z Wrist Blood Pressure Monitor Omron Healthcare, Inc.
K163235 11/17/2016 HEM-9210T Omron Healthcare, Inc.
K183215 11/19/2018 Focus TENS Therapy, Model PM710-M/-L Omron Healthcare, Inc.


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