Product Code: DXN


Products Classified as DXN

821System, Measurement, Blood-pressure, Non-invasiveNoninvasive Blood Pressure Measurement System.

Total Product Life Cycle (TPLC) Devices

821System, Measurement, Blood-pressure, Non-invasiveNoninvasive Blood Pressure Measurement System.

FDA Consensus Standards

System, Measurement, Blood-Pressure, Non-Invasive [37728]21 CFR §870.1130 🔎
System, Measurement, Blood-Pressure, Non-Invasive [31336]21 CFR §870.1130 🔎
System, Measurement, Blood-Pressure, Non-Invasive [38116]21 CFR §870.1130 🔎

Pre-market Notifications for DXN

K221913Arm Blood Pressure MonitorAlicn Medical Shenzhen,Inc
K221764InBody Blood Pressure Monitor, Model BPBIO480KVInBody Co, Ltd.
K221212Upper Arm Blood Pressure MonitorShenzhen Yolanda Technology Co., Ltd
K221040Electronic Sphygmomanometers, Model: X1, X2, X5, X6, X7,X8, X11)Jiangxi AICARE Medical Technology Co., Ltd
K220886Upper Arm Type Blood Pressure MonitorShenzhen Jamr Technology Co.,Ltd
K220651Wrist Type Blood Pressure MonitorShenzhen Jamr Medical Technology Co., Ltd
K220113Upper Arm Electronic Blood Pressure Monitor(Model FC-BP100,FC-BP101,FC-BP102,FC-BP110,FC-BP111,FC-BP112)Shenzhen Finicare Co., Ltd.
K220106QardioArm 2Qardio Inc
K213699CareTaker Monitor AppCaretaker Medical, LLC
K213503Wrist Blood Pressure Monitor, Models AOJ-35A, AOJ-35B, AOJ-35C, AOJ-35D, AOJ-35EShenzhen AOJ Medical Technology Co., Ltd.
K213023Blood Pressure Monitor(Model:Y30001)Zhangzhou Easepal Medical Science And Technology Co.,LTD
K212877Arm Blood Pressure MonitorAlicn Medical Shenzhen,Inc
K212312RA-T59 Wrist Blood Pressure MonitorLotusNine Medical Limited
K212168A&D Medical UM-212BLE Blood Pressure MonitorA&D Company, Ltd
K212115Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure MonitorJOYTECH HEALTHCARE CO.,LTD

Global Unique Device Identification Database

00605388577221System, Measurement, Blood-Pressure, Non-Invasive
10605388044263System, Measurement, Blood-Pressure, Non-Invasive
10605388043860System, Measurement, Blood-Pressure, Non-Invasive
00372217004028System, Measurement, Blood-Pressure, Non-Invasive
00372217004011System, Measurement, Blood-Pressure, Non-Invasive
00370393904019System, Measurement, Blood-Pressure, Non-Invasive
00370393903012System, Measurement, Blood-Pressure, Non-Invasive
10370393902012System, Measurement, Blood-Pressure, Non-Invasive
10370393901015System, Measurement, Blood-Pressure, Non-Invasive
10311917194643System, Measurement, Blood-Pressure, Non-Invasive
10311917194636System, Measurement, Blood-Pressure, Non-Invasive
10311917183418System, Measurement, Blood-Pressure, Non-Invasive
10311917183401System, Measurement, Blood-Pressure, Non-Invasive
10311917183395System, Measurement, Blood-Pressure, Non-Invasive
10311917183388System, Measurement, Blood-Pressure, Non-Invasive

Maude Adverse Events

SAFEDRAW BLOOD SAMPLING SYSTEMMERIT MEDICAL SINGAPORE PTE LTD.2020-03-25
SAFEDRAW BLOOD SAMPLING SYSTEMMERIT MEDICAL SINGAPORE PTE LTD.2020-03-19
SAFEDRAW BLOOD SAMPLING SYSTEMMERIT MEDICAL SINGAPORE PTE LTD.2020-03-19
SAFEDRAW BLOOD SAMPLING SYSTEMMERIT MEDICAL SINGAPORE PTE LTD.2020-03-13
OMRON 3 SERIES UPPER ARM BLOOD PRESSURE MONITOROMRON HEALTHCARE CO., LTD.2020-03-12
FINGER CUFFEDWARDS LIFESCIENCES DR2020-03-12
OMRON 3 SERIES UPPER ARM BLOOD PRESSURE MONITOROMRON HEALTHCARE MANUFACTURING VIETNAM CO., LTD.2020-03-11
SAFEDRAW BLOOD SAMPLING SYSTEMMERIT MEDICAL SINGAPORE PTE LTD.2020-03-06
SURESIGNS VS2+ NBP/SPO2PHILIPS MEDICAL SYSTEMS2020-03-04
SURESIGNS VSI - NBP/SPO2PHILIPS MEDICAL SYSTEMS2020-03-04
SAFEDRAW BLOOD SAMPLING SYSTEMMERIT MEDICAL SINGAPORE PTE LTD.2020-02-27
DTX PLUS DISPOSABLE PRESSURE TRANSDUCERMERIT MEDICAL SINGAPORE PTE LTD.2020-02-26
WITHINGS, WPM05GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO.,LTD2020-02-26
OSCAR 2, 250DSUNTECH MEDICAL, INC.2020-02-19
VS4 VITAL SIGNS MONITORPHILIPS MEDICAL SYSTEMS2020-02-19
OSCAR 2, 250DSUNTECH MEDICAL, INC.2020-02-18
OSCAR 2, 250DSUNTECH MEDICAL, INC.2020-02-18
VS4 VITAL SIGNS MONITORPHILIPS MEDICAL SYSTEMS2020-02-03
SAFEDRAW BLOOD SAMPLING SYSTEMMERIT MEDICAL SINGAPORE PTE LTD.2020-01-31
VS4 VITAL SIGNS MONITORPHILIPS MEDICAL SYSTEMS2020-01-30
SAFEDRAW BLOOD SAMPLING SYSTEMMERIT MEDICAL SINGAPORE PTE LTD.2020-01-22
VS4 VITAL SIGNS MONITORPHILIPS MEDICAL SYSTEMS2020-01-22
UNIVERSAL CUFF COVER STANDARD SIZESPACELABS HEALTHCARE LTD.2020-01-17
SURESIGNS VSI - NBP/SPO2PHILIPS MEDICAL SYSTEMS2020-01-16
SAFEDRAW BLOOD SAMPLING SYSTEMMERIT MEDICAL SINGAPORE PTE LTD.2020-01-15
SAFEDRAW BLOOD SAMPLING SYSTEMMERIT MEDICAL SINGAPORE PTE LTD.2020-01-15
SAFEDRAW BLOOD SAMPLING SYSTEMMERIT MEDICAL SINGAPORE PTE LTD.2020-01-15
WITHINGS - BPW CONNECT AUTOMATIC BLOOD PRESSURE MONITOR - WHITE/GRAYWITHINGS S. A.2020-01-08
SAFEDRAW BLOOD SAMPLING SYSTEMMERIT MEDICAL SINGAPORE PTE LTD.2020-01-08
VS4 VITAL SIGNS MONITORPHILIPS MEDICAL SYSTEMS2020-01-06
FINGER CUFFEDWARDS LIFESCIENCES DR2019-10-15
DRIVE MEDICAL AUTOMATIC BLOOD PRESSURE MONITORDRIVE MEDICAL / DRIVE DEVILBISS HEALTHCARE LIMITED2019-10-07
SMALL CUFFUNK2019-09-27
LARGE CUFFUNK2019-09-27
BLOOD PRESSURE MACHINEUNK2019-09-27
OMRON BLOOD PRESSURE MONITOR, BP786NOMRON HEALTHCARE, INC.2019-09-25
VS4 VITAL SIGNS MONITORPHILIPS MEDICAL SYSTEMS2019-09-24
VS4 VITAL SIGNS MONITORPHILIPS MEDICAL SYSTEMS2019-09-14
VS4 VITAL SIGNS MONITORPHILIPS MEDICAL SYSTEMS2019-09-03
VS4 VITAL SIGNS MONITORPHILIPS MEDICAL SYSTEMS2019-08-29
CLEARSIGHT FINGER CUFFEDWARDS LIFESCIENCES DR2019-08-23
VS4 VITAL SIGNS MONITORPHILIPS MEDICAL SYSTEMS2019-08-21
VS4 VITAL SIGNS MONITORPHILIPS MEDICAL SYSTEMS2019-08-14
EV1000NIEDWARDS LIFESCIENCES2019-08-07
VS4 VITAL SIGNS MONITORPHILIPS MEDICAL SYSTEMS2019-08-07
VS4 VITAL SIGNS MONITORPHILIPS MEDICAL SYSTEMS2019-08-06
VS4 VITAL SIGNS MONITORPHILIPS MEDICAL SYSTEMS2019-08-01
VS4 VITAL SIGNS MONITORPHILIPS MEDICAL SYSTEMS2019-08-01
OMRON 3 SERIES UPPER ARM BLOOD PRESSURE MONITOROMRON HEALTHCARE CO., LTD.2019-08-01
CLEARSIGHT FINGER CUFFEDWARDS LIFESCIENCES DR2019-07-30

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