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FDA 510(k)

Arm-type Electronic Blood Pressure Monitor

K-Number: K183058 · 2019-07-03

ApplicantShenzhen Bsx Technology Electronics Co., Ltd.
Decision Date2019-07-03
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Arm-type Electronic Blood Pressure Monitor is a medical device manufactured by Shenzhen Bsx Technology Electronics Co., Ltd.. It received FDA 510(k) clearance on 2019-07-03 under approval number K183058. 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 Arm-type Electronic Blood Pressure Monitor?

Arm-type Electronic Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2019-07-03. It is manufactured by Shenzhen Bsx Technology Electronics Co., Ltd.. The 510(k) number is K183058.

When was Arm-type Electronic Blood Pressure Monitor approved by the FDA?

Arm-type Electronic Blood Pressure Monitor received FDA 510(k) clearance on 2019-07-03, under approval number K183058.

What company makes Arm-type Electronic Blood Pressure Monitor?

Arm-type Electronic Blood Pressure Monitor is manufactured by Shenzhen Bsx Technology Electronics Co., Ltd..

What is the FDA product code for Arm-type Electronic Blood Pressure Monitor?

The FDA product code for Arm-type Electronic Blood Pressure Monitor is DXN.

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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: 40388896 Accuracy and Safety of a Continuous Noninvasive Blood Pressure Monitor in Neonates. Neonatology (2025)

Other Devices by Shenzhen Bsx Technology Electronics Co., Ltd.

K202324Fingertip Pulse Oximeter K202296Infrared Forehead Thermometer, Model BSX976 K230097IPL Hair Removal Device, Model(s): BSXT101, BSXT102, BSXT103, BSXT105, BSXT106, BSXT108 K241578Wrist Digital Blood Pressure Monitor (BSX312, BSX313, BSX315, BSX322, BSX323, BSX353, BSX355)

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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