Digital Blood Pressure Monitor (Model: YB-800)

FDA 510(k) K231478 · Wenzhou Yosun Medical Technology Co.,Ltd

Substantially Equivalent

510(k) numberK231478

Submission

Device name
Digital Blood Pressure Monitor (Model: YB-800)
Applicant
Wenzhou Yosun Medical Technology Co.,Ltd
Wenzhou, CN
Received
May 22, 2023
Decision date
December 15, 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

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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

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Questions and answers

When was Digital Blood Pressure Monitor (Model: YB-800) cleared by the FDA?

Digital Blood Pressure Monitor (Model: YB-800) (K231478) received a 510(k) decision of Substantially Equivalent on December 15, 2023, 207 days after the submission was received.

What is the product code of K231478?

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