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
2008-08-08
DXN
2008-07-31
KD-391 SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
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DXN
2008-07-31
STATMAP, MODEL 7200
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DXN
2008-07-02
KD-591 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
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DXN
2008-06-19
YA HORNG ARM TYPE DIGITAL BLOOD PRESSURE MONITOR, MODELS BP-600, BP-600R, BP-600U, BP-600B, BP-600RB, BP-600UB, BP-600J
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DXN
2008-05-13
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL BP3MQ1-2D
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DXN
2008-05-09
WRIST BLOOD PRESSURE MONITOR, MODEL WS-1100/WS-1100PV
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DXN
2008-04-23
AMBULO 2400
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DXN
2008-04-03
BLOOD PRESSURE MONITOR, MODELS BP-102, BP-103, BP-201 AND BP-202
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DXN
2008-04-02
CLEVER TD-3026 DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL TD-3026
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DXN
2008-02-26
1500 PRO
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DXN
2008-02-25
YA HORNG DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, BP-100J, BP-110J; DIGITAL WRIST BLOOD PRESSURE MONITOR, BP-500,BP-500
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DXN
2008-01-11
MODIFICATION TO: BPCARD, MODEL Z-7000-0700
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DXN
2008-01-11
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL WATCHBP HOME (BP3MX1-1)
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DXN
2007-12-20
MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3MK1-3 (BP W100)
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DXN
2007-12-20
MICROLIFE UPPER ARM MANUAL BLOOD PRESSURE MONITOR, MODEL BP3MR1-H (BP A50)
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DXN
2007-12-07
AVITA BLUETOOTH BLOOD PRESSURE MONITOR, MODEL: BPM656ZB
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DXN
2007-11-29
MOBIL-O-GRAPH NG 24 H ABP-CONTROL
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DXN
2007-11-29
CONTINUOUS NON-INVASIVE CARDIAC OUTPUT AND BLOOD PRESSURE MONITOR WITH REAL-TIME HEMODYNAMICS
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DXN
2007-11-15
A-PLUS ARTERIAL PULSE WAVEFORM ANALYSIS SYSTEM AND PC SOFTWARE
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DXN
2007-10-09
MODIFICATION TO: DIGITAL BLOOD PRESSURE MONITOR, MODEL 1901
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DXN
2007-09-07
HONEYWELL HOMMED CENTRAL STATION 4.0
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DXN
2007-08-15
KD-595 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
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DXN
2007-08-15
KD-795 WRIST MEASUREMENT ELECTRONIC BLOOD PRESSURE MONITOR
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DXN
2007-08-13
TESLA NIBP
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DXN
2007-08-08
FB-100U SERIES DIGITAL BLOOD PRESSURE MONITOR
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DXN
2007-08-03
MEDITECH AMBULATORY BLOOD PRESSURE MONITOR, MODEL ABPM-05
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DXN
2007-06-26
FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODELS BP1600, BP1650, BP1700 AND BP1750
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DXN
2007-06-07
KD-525E FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
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DXN
2007-06-07
HEALTH CHECK KIOSK
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DXN
2007-05-25
TERUMO DIGITAL BLOOD PRESSURE MONITOR ES-H55A
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DXN
2007-05-25
LD8 DIGITAL WRIST BLOOD PRESSURE MONITOR
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DXN
2007-05-23
BLOOD PRESSURE MONITOR, MODELS ZSBP-OXX AND ZSBP-1XX
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DXN
2007-05-10
SENSACARE MODEL SAA-102 ARM TYPE DIGITAL BLOOD PRESSURE MONITOR
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DXN
2007-05-02
247 BP DEVICE
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DXN
2007-05-01
PHARMASMART PUBLIC USE BLOOD PRESSURE MONITOR, MODELS PS-1000/PS-1500/PS-2000
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DXN
2007-03-23
BP 101 DIGITAL BLOOD PRESSURE MONITOR
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DXN
2007-03-07
BP-200 PLUS
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DXN
2007-02-05
KODEA, MODELS XJ-2001AC; XJ-2002AS; XJ-2003A
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DXN
2007-02-01
FINOMETER MODEL-2 WITH ACCESSORIES
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DXN
2007-01-19
A&D MEDICAL UA-789 DIGITAL BLOOD PRESSURE MONITOR
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DXN
2006-11-08
SENSACARE SAW-102 WRIST DIGITAL BLOOD PRESSURE MONITOR
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DXN
2006-09-29
NON-INVASIVE BLOOD PRESSURE MONITOR, MODELS FT-500R/L AND FT-700R/L
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DXN
2006-09-15
FUSION
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DXN
2006-09-11
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL BP3MC1-PC
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DXN
2006-08-22
MYTECH / HAPPY LIFE / MAXIAIDS ARM BLOOD PRESSURE MONITOR, HPL-301, HPL-302, HPL-310, 180310
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DXN
2006-08-18
LD-578 FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
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DXN
2006-08-14
ARM BLOOD PRESSURE MONITOR, MODEL KP-7600
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DXN
2006-08-10
DM-3000 DIGITAL BLOOD PRESSURE MONITOR
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DXN
2006-08-02
OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH COMFIT CUFF, MODEL HEM 780 N3
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DXN
2006-07-12
TF-BP01 BLOOD PRESSURE MEASUREMENT SYSTEM
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DXN
2006-06-29
MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3BU1-4U
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DXN
2006-06-26
BLOOD PRESSURE METER, MODEL CH-311B
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DXN
2006-06-21
A & D MEDICAL UM-101 DIGITAL BLOOD PRESSURE MONITOR
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DXN
2006-06-14
MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3AX1-4U
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DXN
2006-06-09
MICROLIFE AUTOMATIC BLOOD PRESSURE MONITOR, MODEL BP3AC1-1PC
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DXN
2006-06-07
CYCLE BP MONITOR AND PULSE OXIMETER, MODEL 1060
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DXN
2006-06-02
CLEVER CHECK TD-3250 BLOOD GLUCOSE AND BLOOD PRESSURE MEASUREMENT SYSTEM, MODEL TD-3250
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DXN
2006-05-09
ACON AUTOMATIC BLOOD PRESSURE MONITOR KIT, MODEL OB11-111, W/AC ADAPTER, MODEL OB11-112
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DXN
2006-05-05
HOMMED CENTRAL STATION, VERSION 3.5
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DXN
2006-04-21
HL888SF
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DXN
2006-04-12
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168FV
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DXN
2006-04-07
HEALTHSTATS BPRO AMBULATORY BLOOD PRESSURE MONITORING SYSTEM
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DXN
2006-04-04
PMP4 BP PRO BLOOD PRESSURE MONITOR
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DXN
2006-04-04
ROSSMAX AUTOMATIC BLOOD PRESSURE MONITOR MODEL MO701K
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DXN
2006-03-14
IDEAL LIFE BP-MANAGER, MODEL BPM 0001; IDEAL LIFE POD, MODEL ILP 0001
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DXN
2006-03-08
RTT DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL RTW-8010A
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DXN
2006-02-28
KD-788 WRIST MEASUREMENT ELECTRONIC BLOOD PRESSURE MONITOR
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DXN
2006-02-17
KD-322 SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
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DXN
2006-02-13
MARCH HEALTHCARE HEALTH MONITORING KIT
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DXN
2006-02-03
HOCA EZ-CARE BP108, TENDER-CARE BP109
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DXN
2006-01-24
PRIMO NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM
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DXN
2006-01-05
TANGO+ AUTOMATIC BLOOD PRESSURE AND OXYGEN SATURATION MEASUREMENT SYSTEM
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DXN
2006-01-05
KD-768 WRIST MEASUREMENT ELECTRONIC BLOOD PRESSURE MONITOR
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DXN
2005-12-30
COMMANDER III NON-INVASIVE BLOOD PRESSURE SYSTEM
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DXN
2005-12-30
CARDIOCOM COMMANDER III
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DXN
2005-12-27
FETALGARD LITE-NIBP, MODEL FGL-NIBP
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DXN
2005-12-23
BP PRO BLOOD PRESSURE MONITOR
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DXN
2005-12-16
ROSSMAX NON-INVASIVE BLOOD PRESSURE MONITORS, MODELS S380, K350
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DXN
2005-11-23
IDOC UPPER ARM ATTACHED BLOOD PRESSURE AND PULSE RATE MONITOR, MODEL ID-42A/ID-43A
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DXN
2005-11-22
DEVICE CONNECTIVITY SOFTWARE DEVELOPERS KIT (SDK), MODEL 4500-900
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DXN
2005-11-18
MEDITECH MODEL ABPM-04
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DXN
2005-10-28
OMRON NON-INVASIVE BLOOD PRESSURE MONITOR WITH AUGMENTATION INDEX, MODEL HEM-9000AI
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DXN
2005-10-19
BLOOD PRESSURE METER, MODEL CH-432
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DXN
2005-09-14
PICONIBP OEM MODULE
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DXN
2005-09-12
PROTON DIGITAL BLOOD PRESSURE MONITOR, MODELS PH168A, PH168E, PH168W, PHC888JA, PH888HA
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DXN
2005-09-08
OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-711AC
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DXN
2005-09-08
OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-741CREL
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DXN
2005-08-23
PC COMPATIBLE BLOOD PRESSURE MONITOR, MODEL AK-4000TU, BP-410U, BP-410R; AUTOMATIC DIGITAL WRIST BLOOD PRESS. MONITOR.
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DXN
2005-08-19
AMLUCK, YA HORNG
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DXN
2005-08-12
CLEVER TD-3018A BLOOD PRESSURE MONITOR
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DXN
2005-08-09
BR 102 PLUS BLOOD PRESSURE HOLTER SYSTEM
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DXN
2005-07-28
VITAL SIGNS MONITOR
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DXN
2005-07-01
THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90 INTELLIVUE PATIENT MONITORS
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DXN
2005-06-24
BPCALIBRATOR MC3000/MC3100
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DXN
2005-05-13
BLOOD PRESSURE MONITOR WITH SPECTRUM/P2, X2, A2, AND K7
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DXN
2005-04-21
MODIFICATION TO ARM BLOOD PRESSURE MONITOR, MODELS KP-6821, KP-6822
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DXN
2005-04-08
BLOOD-PRESSURE METER, BPW120
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DXN
2005-04-07
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL168GA, HL168GS
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DXN
2005-04-07
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168JT
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