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
2023-05-19
DXN
2023-05-05
Arm Blood Pressure Monitor, Model Name:111, Arm Blood Pressure Monitor, Model Name: B1681, Arm Blood Pressure Monitor, Model Name: B1682, Arm Blood Pressure Monitor, Model Name: B1683
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DXN
2023-04-21
CONNEQT PULSE
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DXN
2023-04-12
Task Force CORE
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DXN
2023-04-10
Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure Monitor
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DXN
2023-03-03
Electronic Sphygmomanometers
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DXN
2023-02-15
Arm Blood Pressure Monitor
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DXN
2023-02-03
Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular (TWIN200 VSR)
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DXN
2022-12-01
Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D, AOJ-30E, AOJ-30F and AOJ-30G
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DXN
2022-11-22
GUS610 Blood pressure monitor
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DXN
2022-11-07
HemoSphere Advanced Monitor, HemoSphere ClearSight Module
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DXN
2022-10-17
YUWELL Electronic Blood Pressure Monitor
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DXN
2022-10-12
Arm Blood Pressure Monitor
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DXN
2022-10-07
InBody Blood pressure monitor, Model BPBIO480KV
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DXN
2022-10-06
A&D Medical UM-212BLE Blood Pressure Monitor
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DXN
2022-10-03
Electronic Sphygmomanometer (Model: LT-P30)
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DXN
2022-09-30
Blood Pressure Monitor(Model:Y30001)
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DXN
2022-08-31
Electronic Sphygmomanometers, Model: X1, X2, X5, X6, X7,X8, X11)
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DXN
2022-08-30
INDEX BPM
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DXN
2022-08-29
Blood Pressure Monitor
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DXN
2022-08-26
Upper Arm Blood Pressure Monitor
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DXN
2022-07-27
Upper Arm Type Blood Pressure Monitor
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DXN
2022-06-30
Wrist Type Blood Pressure Monitor
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DXN
2022-06-15
QardioArm 2
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DXN
2022-05-31
Upper Arm Electronic Blood Pressure Monitor(Model FC-BP100,FC-BP101,FC-BP102,FC-BP110,FC-BP111,FC-BP112)
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DXN
2022-05-04
LiveOne
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DXN
2022-03-30
CareTaker Monitor App
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DXN
2022-03-01
Wrist-type Fully Automatic Digital Blood Pressure Monitor
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DXN
2022-02-18
Wrist Blood Pressure Monitor, models AOJ-35A, AOJ-35B, AOJ-35C, AOJ-35D, AOJ-35E
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DXN
2022-01-27
RA-T59 Wrist blood pressure monitor
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DXN
2022-01-19
Arm Blood Pressure Monitor, model OB30, OB31, OB32, OB33
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DXN
2022-01-12
Arm Blood Pressure Monitor
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DXN
2022-01-05
Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor
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DXN
2021-11-04
Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B
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DXN
2021-11-01
Electronic Blood Pressure Monitor
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DXN
2021-10-15
Arm Blood Pressure Monitor
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DXN
2021-10-01
Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09
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DXN
2021-09-23
Automatic Digital Blood Pressure Monitor
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DXN
2021-09-08
Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DM
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DXN
2021-08-30
Wrist Blood Pressure Monitor, Model Name:W203, Wrist Blood Pressure Monitor, Model Name:W202, Wrist Blood Pressure Monitor, Model Name:W1681
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DXN
2021-08-13
Caretaker Platform, VitalStream Platform, CT5
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DXN
2021-08-13
Digital Blood Pressure Monitor WBP Series, including: WBP101, WBP102, WBP103, WBP104, WBP105, WBP106, WBP107
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DXN
2021-07-30
Wrist Blood Pressure Monitor, Blood Pressure Monitor
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DXN
2021-07-29
Arm Blood Pressure Monitor, Wireless Blood Pressure Monitor
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DXN
2021-06-07
HRVWatch-Mini Wrist Monitor
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DXN
2021-05-12
Automatic Arm Electronic Blood Pressure Monitor
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DXN
2021-04-28
CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer, ABPM50 Automatic Blood Pressure Monitor
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DXN
2021-04-08
Microlife Upper Arm Automatic Digital Blood Pressure Monitor
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DXN
2021-04-01
Omron Model BP7900 Blood Pressure Monitor + EKG
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DXN
2021-03-09
Blood Pressure Monitor
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DXN
2021-02-10
Meditech ABPM-06 (BP6)
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DXN
2021-01-27
Arm Electronic Sphygmomanometer
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DXN
2021-01-27
Wrist Electronic Sphygmomanometer
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DXN
2021-01-26
Blood Pressure Monitor
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DXN
2021-01-22
EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical Platform
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DXN
2021-01-06
InBody
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DXN
2020-12-30
Upper Arm Electronic Blood Pressure Monitor
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DXN
2020-12-17
Wrist Type Blood Pressure Monitor
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DXN
2020-12-06
Transtek Wrist Blood Pressure Monitor
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DXN
2020-12-04
Electronic Blood Pressure Monitor
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DXN
2020-12-04
InBody
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DXN
2020-10-09
V20, V20a, AVSM3 SNF
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DXN
2020-09-21
Blood Pressure Monitor-Model 2005, 2006-2, 2006-2B
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DXN
2020-08-20
Electronic Blood Pressure Monitor
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DXN
2020-08-03
Arm-Type Fully Automatic Digital Blood Pressure Monitor
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DXN
2020-07-23
Microlife Upper Arm Automatic Digital Blood Pressure Monitor
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DXN
2020-07-16
Arm Blood Pressure Monitor
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DXN
2020-07-12
AGE Automatic Wrist Blood Pressure Monitor
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DXN
2020-07-12
Automatic Upper Arm Blood Pressure Monitor
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DXN
2020-07-10
Automatic Upper Arm Blood Pressure Monitor
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DXN
2020-06-25
Blood Pressure Monitor
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DXN
2020-06-25
Blood Pressure Monitor
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DXN
2020-06-18
Microlife Upper Arm Automatic Digital Blood Pressure Monitor
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DXN
2020-06-12
Full Automatic(NIBP) Blood Pressure Monitor
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DXN
2020-05-29
Automatic Digital Blood Pressure Monitor
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DXN
2020-05-15
BP-BT Kiosk
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DXN
2020-05-15
Medtronic Commander Flex
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DXN
2020-04-21
Globalcare Blood Pressure Monitor
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DXN
2020-02-21
Upper Arm Blood Pressure Monitor
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DXN
2020-01-23
Seca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA, Seca 535
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DXN
2019-12-23
Arm Blood Pressure Monitor
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DXN
2019-11-27
Upper Arm Blood Pressure Monitor
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DXN
2019-09-16
Full Automatic (NIBP) Blood Pressure Monitor
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DXN
2019-09-11
CNAP Monitor
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DXN
2019-08-30
EV1000 Clinical Platform NI, EV1000 Clinical Platform
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DXN
2019-08-23
Electronic Blood Pressure Monitor
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DXN
2019-08-19
Blood Pressure Monitor
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DXN
2019-08-07
Non-invasive Hemodynamic Blood Pressure Monitor
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DXN
2019-08-02
Med-link Wrist Digital Blood Pressure Monitor, Med-link Upper Arm Digital Blood Pressure Monitor
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DXN
2019-07-29
Non-invasive blood pressure measurement systems
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DXN
2019-07-22
Digital Automatic Blood Pressure Monitor MD36 Series
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DXN
2019-07-10
Microlife Upper Arm Automatic Digital Blood Pressure Monitor
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DXN
2019-07-03
Arm-type Electronic Blood Pressure Monitor
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DXN
2019-06-24
Oscillometric Blood Pressure Monitor
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DXN
2019-06-21
The ClearSight finger cuffs
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DXN
2019-06-13
Full Automatic (NIBP) Blood Pressure Monitor-HL158UB
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DXN
2019-06-04
Fully Automatic Electronic Blood Pressure Monitor
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DXN
2019-05-20
Full Automatic (NIBP) Blood Pressure Monitor-HL158TB
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DXN
2019-05-16
Fully Automatic Electronic Blood Pressure Monitor
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DXN
2019-05-16
Tel-O-Graph
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