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FDA 510(k)

Wrist Type Blood Pressure Monitor (W05,W1101L)

K-Number: K230409 · 2023-08-25

ApplicantShenzhen Jamr Technology Co., Ltd.
Decision Date2023-08-25
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Wrist Type Blood Pressure Monitor (W05,W1101L) is a medical device manufactured by Shenzhen Jamr Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-08-25 under approval number K230409. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Wrist Type Blood Pressure Monitor (W05,W1101L)?

Wrist Type Blood Pressure Monitor (W05,W1101L) is a medical device that received FDA 510(k) clearance on 2023-08-25. It is manufactured by Shenzhen Jamr Technology Co., Ltd.. The 510(k) number is K230409.

When was Wrist Type Blood Pressure Monitor (W05,W1101L) approved by the FDA?

Wrist Type Blood Pressure Monitor (W05,W1101L) received FDA 510(k) clearance on 2023-08-25, under approval number K230409.

What company makes Wrist Type Blood Pressure Monitor (W05,W1101L)?

Wrist Type Blood Pressure Monitor (W05,W1101L) is manufactured by Shenzhen Jamr Technology Co., Ltd..

What is the FDA product code for Wrist Type Blood Pressure Monitor (W05,W1101L)?

The FDA product code for Wrist Type Blood Pressure Monitor (W05,W1101L) is DXN.

Related Clinical Trials

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Related PubMed Literature

PMID: 41836285 A Case Study of AI-Enabled Software as a Medical Device Cleared by the FDA for Assessing Hemorrhage Risk Index (APPRAISE-HRI) after Trauma. NEJM AI (2025) PMID: 41623865 Case Report: Hypertensive encephalopathy presents with complex types of sleep breathing events. Frontiers in cardiovascular medicine (2025)

Other Devices by Shenzhen Jamr Technology Co., Ltd.

K200437Blood Pressure Monitor K220886Upper Arm Type Blood Pressure Monitor K233823Ultrasonic Fetal Doppler K233146Blood Pressure Monitor K251331Blood Pressure Monitor (B73, BE23T)

Related Devices (Code: DXN)

K162092Evolv Model BP7000 Upper Arm Blood Pressure MonitorOmron Healthcare, Inc. K161708Arm automatic blood pressure monitorShenzhen Pump Medical System Co., Ltd. K162230Fully Automatic Electronic Blood Pressure MonitorAdon Health Co., Ltd. K160349Electronic SphygmomanometerGuangdong Biolight Meditech Co., Ltd. K161846Automatic Arm Bluetooth Blood Pressure MonitorTruly Instrument Limited K161886Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure DeviceGuangdong Transtek Medical Electronics Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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