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FDA 510(k)

Clinical Automatic Blood Pressure Monitor (DBP-01P,DBP-01HP)

K-Number: K231984 · 2024-03-26

ApplicantShenzhen Hingmed Medical Instrument Co., Ltd.
Decision Date2024-03-26
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Clinical Automatic Blood Pressure Monitor (DBP-01P,DBP-01HP) is a medical device manufactured by Shenzhen Hingmed Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2024-03-26 under approval number K231984. 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 Clinical Automatic Blood Pressure Monitor (DBP-01P,DBP-01HP)?

Clinical Automatic Blood Pressure Monitor (DBP-01P,DBP-01HP) is a medical device that received FDA 510(k) clearance on 2024-03-26. It is manufactured by Shenzhen Hingmed Medical Instrument Co., Ltd.. The 510(k) number is K231984.

When was Clinical Automatic Blood Pressure Monitor (DBP-01P,DBP-01HP) approved by the FDA?

Clinical Automatic Blood Pressure Monitor (DBP-01P,DBP-01HP) received FDA 510(k) clearance on 2024-03-26, under approval number K231984.

What company makes Clinical Automatic Blood Pressure Monitor (DBP-01P,DBP-01HP)?

Clinical Automatic Blood Pressure Monitor (DBP-01P,DBP-01HP) is manufactured by Shenzhen Hingmed Medical Instrument Co., Ltd..

What is the FDA product code for Clinical Automatic Blood Pressure Monitor (DBP-01P,DBP-01HP)?

The FDA product code for Clinical Automatic Blood Pressure Monitor (DBP-01P,DBP-01HP) 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) PMID: 40406702 Toward a unified gait freeze index: a standardized benchmark for clinical and regulatory evaluations. Frontiers in neurology (2025)

Other Devices by Shenzhen Hingmed Medical Instrument Co., Ltd.

K251581Wearable Ambulatory Blood Pressure Monitor (WBP-02A) K251307Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i)

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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