System, Measurement, Blood-Pressure, Non-Invasive
FDA product code DXN · 1166 cleared devices
Class 2
Cardiovascular
- Regulation
- 21 CFR 870.1130
- Review panel
- CV
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1976-11-09 – 2026-09-10
DXN
2013-11-14
DXN
2013-10-23
AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
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DXN
2013-10-07
HEM-6221
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DXN
2013-09-17
ELECTRONIC BLOOD PRESSURE MONITOR FOR UPPER ARM
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DXN
2013-09-17
ANSWATCH WRIST MONITOR MODEL TS-0411
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DXN
2013-09-12
AUTOMATIC BLOOD PRESSURE MONITOR
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DXN
2013-09-04
BIOSPACE
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DXN
2013-08-30
PG-800B SERIES, INCLUDING PG-800BD, PG-800B-1, PG-800BD-1, PG-800B3, PG-800B4, PG-800B4D, PG-800B5, PG-800B5-1, PG-800B6
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DXN
2013-08-14
AGE AUTOMATIC UPPER ARM BLOOD PRESSURE MONITOR
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DXN
2013-07-24
HEM-6131
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DXN
2013-07-19
IHEALTH CLOUD
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DXN
2013-07-08
WRIST AUTOMATIC BLOOD PRESSURE MONITOR
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DXN
2013-06-19
TRANSTEK BLOOD PRESSURE MONITOR
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DXN
2013-06-19
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR
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DXN
2013-06-18
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR
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DXN
2013-06-14
PG-800A SERIES
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DXN
2013-06-06
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
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DXN
2013-05-29
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR
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DXN
2013-05-15
WRIST AUTOMATIC BLOOD PRESSURE MONITOR
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DXN
2013-05-13
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, CARDIO+ (BP4GAPO-2M)
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DXN
2013-05-03
DIGITAL BLOOD PRESSURE MONITOR
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DXN
2013-04-22
STAYHEALTHY HEALTH KIOSK, STAYHEALTHY HEALTHCENTER KIOSK
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DXN
2013-04-22
NEXFIN MODEL 2
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DXN
2013-04-15
PERSONAL HEALTH CENTER (PHC)
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DXN
2013-03-21
BP652N (HEM-6300-Z)
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DXN
2013-03-21
APPS-HEALTH01
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DXN
2013-03-11
DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM03 SERIES MODEL MD03X0
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DXN
2013-03-01
TRANSTEK BLOOD PRESSURE MONITOR
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DXN
2013-02-14
DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM11 SERIES
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DXN
2013-02-14
DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM15 SERIES
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DXN
2013-02-08
COMPACT DIGITAL BLOOD PRESSURE MONITOR
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DXN
2013-01-11
WA SERIES: WA100; WA200; WD100; WE100, WF100; WB200
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DXN
2012-12-21
TRANSTEK WRIST BLOOD PRESSURE MONITOR
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DXN
2012-12-11
CARDIOSCOPE
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DXN
2012-12-07
TL-300 T-LINE NON-INVASIVE BLOOD PRESSURE MONITORING SYSTEM
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DXN
2012-11-28
BLIP MODEL BP-700WF
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DXN
2012-11-20
UFIT TEN-10
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DXN
2012-11-16
SPHYGMOCOR XCEL
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DXN
2012-11-02
TANGO M2 BLOOD PRESSURE MONITOR
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DXN
2012-10-23
HX-461
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DXN
2012-10-22
TRANSTEK WRIST BLOOD PRESSURE MONITOR
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DXN
2012-09-10
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
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DXN
2012-08-29
HEM-7200-Z (BP742)
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DXN
2012-08-17
YA HORNG BLOOD PRESSURE MONITOR, YA HORNG BLOOD PRESSURE MONITOR, BLUETOOTH TRANSMISSION
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DXN
2012-08-14
CONNECTED CARE CLINICAL APPLICATION
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DXN
2012-08-10
ARM-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WRIST-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
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DXN
2012-08-02
MICROLIFE WRIST WATCH BLOOD PREEURE MONITOR, BP3MO1-3P
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DXN
2012-08-02
DISITAL BLOOD PRESSURE MONITOR
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DXN
2012-07-18
WRIST-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
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DXN
2012-07-03
U-RIGHT TD-3124 BLOOD PRESSURE MONITORING SYSTEM
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DXN
2012-06-14
FULLY AUTOMATIC WIRELESS BLOOD PRESSURE WRIST MONITOR
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DXN
2012-06-01
KD-936 FULLY AUTOMATIC WIRELESS BLOOD PRESSURE MONITOR
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DXN
2012-05-30
SOLOHEALTH STATION
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DXN
2012-05-15
TL-200 T-LINE NON-INVASIVE BLOOD PRESSURE MONITORING SYSTEM
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DXN
2012-03-16
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR (MODEL HL168KF)
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DXN
2012-03-02
ELECTRO SENSOR COMPLEX SOFTWARE (ES COMPLEX SOFTWARE)
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DXN
2012-03-01
FULL AUTOMATIC (NIBP) BLOOD PRESSUE MONITOR
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DXN
2012-02-24
BLOOD PRESSURE MONITOR
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DXN
2012-02-24
BLOOD PRESSURE MONITOR
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DXN
2012-02-21
BOKANG SEMI-AUTO / AUTOMATIC / WRIST DIGITAL BLOOD PRESSURE MONITOR
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DXN
2012-02-14
VITAL SIGNS MONITOR
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DXN
2012-02-14
SURESIGNS VS3 VITAL SIGNS MONITOR, SURESIGNS VS4 VITAL SIGNS MONITOR
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DXN
2012-02-10
KINGYIELD WRIST BLOOD PRESSURE MONITOR
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DXN
2012-01-31
TRANSTEK BLOOD PRESSURE MONITOR
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DXN
2012-01-27
MODEL HBP-1300
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DXN
2012-01-19
TRULY AUTOMATIC ARM BLOOD PRESSURE MONITOR
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DXN
2012-01-18
AVITA ARM TYPE BLOOD PRESSURE MONITOR
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DXN
2012-01-12
TRYLY AUTOMATIC WRIST BLOOD PRESSURE MONITOR
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DXN
2011-12-22
U-RIGHT TD-3128 BLOOD PRESSURE MONITORING SYSTEM
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DXN
2011-12-21
FUKUDA DENSHI VASERA MODEL VS-1500
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DXN
2011-12-21
U-RIGHT TD-3135 BLOOD PRESSURE MONITORING SYSTEM
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DXN
2011-12-16
HYPERTENSION MANAGEMENT SOFTWARE CLAIENT SERVER (HMS-CS)
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DXN
2011-12-09
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-7902BTJ, FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MO
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DXN
2011-12-09
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
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DXN
2011-12-05
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
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DXN
2011-11-22
BESTSHAPE BLOOD PRESSURE MONITORING SYSTEM
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DXN
2011-11-22
ACCUMED UPPER ARM AUTOMATIC BLOOD PRESSURE MONITOR
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DXN
2011-11-22
ACCUMED WRIST AUTOMATIC BLOOD PRESSURE MONITOR
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DXN
2011-11-16
HEALTHTRACKER
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DXN
2011-11-10
MULTIFUNCTION KEITO
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DXN
2011-10-20
OSTAR USB BLOOD PRESSURE MONITOR WITH SPECTRUM / P200 FOR UPPER ARM, AND M100 FOR WRIST TYPE
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DXN
2011-10-11
SURESIGNS VS2+ -SURESIGNS VSI
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DXN
2011-09-30
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR
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DXN
2011-08-01
A & D MEDICAL UA-1000 FAMILY DAGITAL BLOOD PRESSURE MONITORS
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DXN
2011-07-27
AMBULATORY BLLOD PRESSURE MONITOR, ELECTRONIC SPHYGMOMANOMETER,
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DXN
2011-07-13
MICROLIFE AUTOMATIC TALKING BLOOD PRESSURE MONITOR
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DXN
2011-07-07
FORA P30 PLUS MULTI-MODE BLOOD PRESSURE MONITORING SYSTEM
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DXN
2011-05-27
TRANSTEK BLOOD PRESSURE MONITOR MODEL TMB-986, TMB-987, TMB-995
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DXN
2011-05-20
SURESIGNS VS2 VITAL SIGNS MONITOR
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DXN
2011-05-20
WITHINGS BLOOD PRESSURE MONITOR
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DXN
2011-05-20
SURESIGNS VSI VITAL SIGNS MONITOR
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DXN
2011-05-13
ELECTRONIC SPHYGMOMANOMETER
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DXN
2011-05-13
ELECTRONIC SPHYGMOMANOMETER
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DXN
2011-03-21
HEM-4030
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DXN
2011-03-21
DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM10 SERIES
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DXN
2011-03-15
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
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DXN
2011-02-23
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-931
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DXN
2011-02-18
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
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DXN
2011-02-18
INFINITY CNAP SMARTPOD
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DXN
2011-02-15
VANTAGE ABI
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