A&D Medical UB-1100BLE UltraConnect Digital Blood Pressure Monitor
K-Number: K170196 · 2017-05-17
ApplicantA&D Company, Ltd.
Decision Date2017-05-17
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
A&D Medical UB-1100BLE UltraConnect Digital Blood Pressure Monitor is a medical device manufactured by A&D Company, Ltd.. It received FDA 510(k) clearance on 2017-05-17 under approval number K170196. 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 A&D Medical UB-1100BLE UltraConnect Digital Blood Pressure Monitor?
A&D Medical UB-1100BLE UltraConnect Digital Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2017-05-17. It is manufactured by A&D Company, Ltd.. The 510(k) number is K170196.
When was A&D Medical UB-1100BLE UltraConnect Digital Blood Pressure Monitor approved by the FDA?
A&D Medical UB-1100BLE UltraConnect Digital Blood Pressure Monitor received FDA 510(k) clearance on 2017-05-17, under approval number K170196.
What company makes A&D Medical UB-1100BLE UltraConnect Digital Blood Pressure Monitor?
A&D Medical UB-1100BLE UltraConnect Digital Blood Pressure Monitor is manufactured by A&D Company, Ltd..
What is the FDA product code for A&D Medical UB-1100BLE UltraConnect Digital Blood Pressure Monitor?
The FDA product code for A&D Medical UB-1100BLE UltraConnect Digital Blood Pressure Monitor is DXN.
Related Clinical Trials
NCT01143558
Searching for Persistence of Infection in Lyme Disease
COMPLETED
NCT07260890
Paired Comparison of SVV and PVI Accuracy
COMPLETED
NCT05452226
Neuromuscular Electrical Stimulation in COPD/Community Acquired Pneumonia
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
Related PubMed Literature
PMID: 42204020
A Minimal UDI-DICOM Mapping Profile and Validation Artifact for Medical-Device Imaging Workflows.
Journal of imaging informatics in medicine (2026)
PMID: 42174919
Automating Safety Surveillance for Software-Based Medical Devices: Insights from FDA MAUDE Data.
Studies in health technology and informatics (2026)
PMID: 42067025
Regulating cybersecurity in digital health: A comparative policy analysis of the USA, EU, and India.
Annales pharmaceutiques francaises (2026)
PMID: 42037982
Ethical, legal, and social implications of AI-enabled digital therapeutics: A comparative analysis of risk-based regulatory frameworks in the European Union and Japan.
Digital health (2026)
Other Devices by A&D Company, 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.