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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