Medical Device Manufacturer · US , Vernon Hills , IL

Omron Healthcare, Inc. - FDA 510(k) Cleared Devices

68 submissions · 67 cleared · Since 1991
68
Total
67
Cleared
1
Denied
41 devices
26-41 of 41
Cleared Jun 09, 2006
PORTABLE, ELECTROCARDIOGRAPH (ECG) MONITOR, MODEL HCG-801
K060766 · DPS
Cardiovascular · 79d
Cleared Oct 28, 2005
OMRON NON-INVASIVE BLOOD PRESSURE MONITOR WITH AUGMENTATION INDEX, MODEL...
K050233 · DXN
Cardiovascular · 269d
Cleared Sep 08, 2005
OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-741CREL
K052153 · DXN
Cardiovascular · 30d
Cleared Sep 08, 2005
OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-711AC
K052154 · DXN
Cardiovascular · 30d
Cleared Apr 05, 2005
OMRON DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL HEM-609N
K042505 · DXN
Cardiovascular · 202d
Cleared Apr 05, 2005
OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-780M
K042506 · DXN
Cardiovascular · 202d
Cleared Nov 10, 2004
OMRON DIGITAL BLOOD PRESSURE MONITOR, MODEL HEM-906
K043018 · DXN
Cardiovascular · 8d
Cleared Feb 11, 2004
OMRON INTELLISENSE DIGITAL BLOOD PRESSURE MONITOR, MODEL HEM-907XL
K032305 · DXN
Cardiovascular · 201d
Cleared Dec 12, 2002
OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODELS HEM-773,...
K021682 · DXN
Cardiovascular · 204d
Cleared Jul 03, 2000
OMRON INTELLISENSE BLOOD PRESSURE MONITOR, MODEL HEM-907
K001848 · DXN
Cardiovascular · 14d
Cleared Jun 30, 2000
AUTOMATIC BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODEL HEM-757
K001670 · DXN
Cardiovascular · 29d
Cleared Jun 30, 2000
ULTRA COMPACT WRIST BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODEL HEM-630
K001671 · DXN
Cardiovascular · 29d
Cleared May 13, 1993
OMRON OSCILLOMETRIC DIGITAL BLOOD PRESSURE MONIT.
K930798 · DXN
Cardiovascular · 86d
Cleared Dec 24, 1992
OMRON WRIST DIGITAL BLOOD PRESSURE MONITOR HEM-601
K920778 · DXN
Cardiovascular · 308d
Cleared Dec 23, 1992
OMRON OSCILLOMETRIC DIGIT BLOOD PRES MONIT-HEM-706
K914823 · DXN
Cardiovascular · 425d
Cleared Nov 06, 1991
AUTO. OSCILLOMETRIC DIGITAL BLOOD PRESS. MONITOR
K913523 · DXN
Cardiovascular · 90d
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