Electronic Blood Pressure Monitor

FDA 510(k) K232814 · Zhuhai Yueja Medical Device Technology Co., Ltd.

Substantially Equivalent

510(k) numberK232814

Submission

Device name
Electronic Blood Pressure Monitor
Applicant
Zhuhai Yueja Medical Device Technology Co., Ltd.
Zhuhai, CN
Received
September 13, 2023
Decision date
December 5, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DXN – System, Measurement, Blood-Pressure, Non-Invasive
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1130
Specialty
Cardiovascular

Other 510(k)s with product code DXN

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K261929Upper Arm Blood pressure monitor (BP7155D)DXN · Special OMRON Healthcare, Inc.09/10/2026SE
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K262658Automatic Digital Blood Pressure monitor (LD-526)DXN · Special Honsun (Nantong) Co., Ltd.08/31/2026SE
K261394Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus…DXN · Traditional JOYTECH Healthcare Co., Ltd.08/26/2026SE
K261061BP Go (BPP-855)DXN · Traditional Wellvii, Inc.08/13/2026SE
K253425Arm-type Fully Automatic Digital Blood Pressure Monitor…DXN · Traditional Joytech Healthcare Co. , Ltd.08/13/2026SE
K261136Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D)DXN · Traditional Guangzhou Daxin Health Technology Co., Ltd.07/23/2026SE
K261082Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)DXN · Traditional Microlife Corporation07/23/2026SE
K253126Wrist Blood Pressure Monitor (XW-05)DXN · Traditional Shenzhen Ziqing Medical Equipment Co., Ltd.06/18/2026SE
K260693VicorderCS (VCS-SYS-1100)DXN · Traditional 80 Beats Medical GmbH06/16/2026SE

More from 80 Beats Medical GmbH

510(k)DeviceDecision
K232473Infrared Thermometer: Model YJ600FLL · Traditional 02/09/2024SE
K232815Wrist Blood Pressure MonitorDXN · Traditional 12/11/2023SE

Questions and answers

When was Electronic Blood Pressure Monitor cleared by the FDA?

Electronic Blood Pressure Monitor (K232814) received a 510(k) decision of Substantially Equivalent on December 5, 2023, 83 days after the submission was received.

What is the product code of K232814?

The FDA product code is DXN – System, Measurement, Blood-Pressure, Non-Invasive, a Class II (moderate risk) device regulated under 21 CFR 870.1130.