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510(k) K241578

Device
Wrist Digital Blood Pressure Monitor (BSX312, BSX313, BSX315, BSX322, BSX323, BSX353, BSX355)
Applicant
Shenzhen Bsx Technology Electronics Co., Ltd.
510(k) number
K241578
Product code
DXN
Decision
Substantially Equivalent (SESE)
Decision date
2025-02-19
Date received
2024-06-03
Regulation
870.1130
Classification name
System, Measurement, Blood-Pressure, Non-Invasive
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
XiYu Lu
Address
Rm101&2/F~4/F, Bldg. #13, Ailian Industrial Park, Wulian Community, Longgang Distric Shenzhen CN 518116 518116

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DXN#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253425Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P)Joytech Healthcare Co. , Ltd.2026-08-13
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K261082Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)Microlife Corporation2026-07-23
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K253126Wrist Blood Pressure Monitor (XW-05)Shenzhen Ziqing Medical Equipment Co., Ltd.2026-06-18
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K253570Blood Pressure Monitor (W06LT)Shenzhen Jamr Technology Co., Ltd.2026-05-20
K254048Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T)Shenzhen Urion Technology Co., Ltd.2026-05-14
K253152BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)Biozen, LLC2026-05-06
K252501Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62E3B, DBP-62E2B, DBP-62E1B, DBP-61E3, DBP-61E2, DBP-61E1, DBP-61D7G, DBP-6281L, DBP-6282L, DBP-6285L)Joytech Healthcare Co. , Ltd.2026-04-28
K260260Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD-581, LD-521, LD-527, LD-572 & LD-569)Honsun (Nantong) Co., Ltd.2026-04-28
K253982Korotkoff sound blood pressure monitorBeijing Hanvon Health Technology Co., Ltd.2026-04-21
K254225Arm Blood Pressure Monitor (HH-802CB, HH-802EB, HH-805CB, HH-812CB, HH-808CL, HH-808EL)Shenzhen HanHan Technology Co., Ltd.2026-04-01