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FDA 510(k)

Digital Automatic Blood Pressure Monitor MD36 Series

K-Number: K191593 · 2019-07-22

ApplicantGrandway Technology (Shenzhen) Limited
Decision Date2019-07-22
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Digital Automatic Blood Pressure Monitor MD36 Series is a medical device manufactured by Grandway Technology (Shenzhen) Limited. It received FDA 510(k) clearance on 2019-07-22 under approval number K191593. 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 Digital Automatic Blood Pressure Monitor MD36 Series?

Digital Automatic Blood Pressure Monitor MD36 Series is a medical device that received FDA 510(k) clearance on 2019-07-22. It is manufactured by Grandway Technology (Shenzhen) Limited. The 510(k) number is K191593.

When was Digital Automatic Blood Pressure Monitor MD36 Series approved by the FDA?

Digital Automatic Blood Pressure Monitor MD36 Series received FDA 510(k) clearance on 2019-07-22, under approval number K191593.

What company makes Digital Automatic Blood Pressure Monitor MD36 Series?

Digital Automatic Blood Pressure Monitor MD36 Series is manufactured by Grandway Technology (Shenzhen) Limited.

What is the FDA product code for Digital Automatic Blood Pressure Monitor MD36 Series?

The FDA product code for Digital Automatic Blood Pressure Monitor MD36 Series 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: 41623865 Case Report: Hypertensive encephalopathy presents with complex types of sleep breathing events. Frontiers in cardiovascular medicine (2025) PMID: 41322758 Real-World Case Series on Surgi-ORC® in ENT Surgery. Cureus (2025) PMID: 40406702 Toward a unified gait freeze index: a standardized benchmark for clinical and regulatory evaluations. Frontiers in neurology (2025)

Other Devices by Grandway Technology (Shenzhen) Limited

K163648Digital Automatic Blood Pressure Monitor BPM41 Series, Digital Automatic Blood Pressure Monitor BPM45 Series K163679Digital Automatic Blood Pressure Monitor MD3600 K163113Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series K171379Digital Automatic Wrist Blood Pressure Monitor MD4300

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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