Non-invasive blood pressure measurement systems
K-Number: K190886 · 2019-07-29
ApplicantJoytech Healthcare Co. , Ltd.
Decision Date2019-07-29
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Non-invasive blood pressure measurement systems is a medical device manufactured by Joytech Healthcare Co. , Ltd.. It received FDA 510(k) clearance on 2019-07-29 under approval number K190886. 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 Non-invasive blood pressure measurement systems?
Non-invasive blood pressure measurement systems is a medical device that received FDA 510(k) clearance on 2019-07-29. It is manufactured by Joytech Healthcare Co. , Ltd.. The 510(k) number is K190886.
When was Non-invasive blood pressure measurement systems approved by the FDA?
Non-invasive blood pressure measurement systems received FDA 510(k) clearance on 2019-07-29, under approval number K190886.
What company makes Non-invasive blood pressure measurement systems?
Non-invasive blood pressure measurement systems is manufactured by Joytech Healthcare Co. , Ltd..
What is the FDA product code for Non-invasive blood pressure measurement systems?
The FDA product code for Non-invasive blood pressure measurement systems is DXN.
Related Clinical Trials
NCT07475091
Standardizing Swallow Pressure Measurements
NOT_YET_RECRUITING
NCT07260890
Paired Comparison of SVV and PVI Accuracy
COMPLETED
NCT07613762
High-Flow Nasal Cannula on Exercise Tolerance in Heart Failure Patients Undergoing Cardiac Rehabilitation.
NOT_YET_RECRUITING
NCT07614100
Cerebral Microembolization During Transcatheter Aortic Valve Implantation: Comparing Balloon-expandable and Self-expanding Valves
NOT_YET_RECRUITING
NCT07499128
Continuous Temperature Monitoring (CTM) for Cytokine Release Syndrome (CRS), an Immune-Related Adverse Event
ENROLLING_BY_INVITATION
NCT07099092
Causal Mechanisms of Odor-Guided Behavior in Humans
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: 41518328
Surface Energy and Pinning Forces of Fluorine-Free, Water-Friendly Coatings for Medical Devices.
Langmuir : the ACS journal of surfaces and colloids (2026)
PMID: 41336744
From laboratory to pre-market prototyping: lessons learned from a noninvasive blood glucose level measurement device.
Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference (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.