Arm-type Fully Automatic Digital Blood Pressure Monitor
K-Number: K231303 · 2024-01-26
ApplicantJoytech Healthcare Co. , Ltd.
Decision Date2024-01-26
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Arm-type Fully Automatic Digital Blood Pressure Monitor is a medical device manufactured by Joytech Healthcare Co. , Ltd.. It received FDA 510(k) clearance on 2024-01-26 under approval number K231303. 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 Fully Automatic Digital Blood Pressure Monitor?
Arm-type Fully Automatic Digital Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2024-01-26. It is manufactured by Joytech Healthcare Co. , Ltd.. The 510(k) number is K231303.
When was Arm-type Fully Automatic Digital Blood Pressure Monitor approved by the FDA?
Arm-type Fully Automatic Digital Blood Pressure Monitor received FDA 510(k) clearance on 2024-01-26, under approval number K231303.
What company makes Arm-type Fully Automatic Digital Blood Pressure Monitor?
Arm-type Fully Automatic Digital Blood Pressure Monitor is manufactured by Joytech Healthcare Co. , Ltd..
What is the FDA product code for Arm-type Fully Automatic Digital Blood Pressure Monitor?
The FDA product code for Arm-type Fully Automatic Digital Blood Pressure Monitor is DXN.
Related Clinical Trials
NCT07260890
Paired Comparison of SVV and PVI Accuracy
COMPLETED
NCT07614139
Continuous Glucose Monitoring Alerts, Accuracy, and Patient Outcomes in Adults With Inherited Metabolic Disorders
COMPLETED
NCT07613762
High-Flow Nasal Cannula on Exercise Tolerance in Heart Failure Patients Undergoing Cardiac Rehabilitation.
NOT_YET_RECRUITING
NCT07301385
Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study
ACTIVE_NOT_RECRUITING
NCT06940752
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
ENROLLING_BY_INVITATION
NCT07614100
Cerebral Microembolization During Transcatheter Aortic Valve Implantation: Comparing Balloon-expandable and Self-expanding Valves
NOT_YET_RECRUITING
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)
PMID: 40075149
Systematic review and meta-analysis on fully automated digital cognitive behavioral therapy for insomnia.
NPJ digital medicine (2025)
Other Devices by Joytech Healthcare Co. , Ltd.
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.