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FDA 510(k)

Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor

K-Number: K151781 · 2016-05-27

ApplicantIvy Biomedical Systems, Inc.
Decision Date2016-05-27
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor is a medical device manufactured by Ivy Biomedical Systems, Inc.. It received FDA 510(k) clearance on 2016-05-27 under approval number K151781. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor?

Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor is a medical device that received FDA 510(k) clearance on 2016-05-27. It is manufactured by Ivy Biomedical Systems, Inc.. The 510(k) number is K151781.

When was Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor approved by the FDA?

Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor received FDA 510(k) clearance on 2016-05-27, under approval number K151781.

What company makes Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor?

Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor is manufactured by Ivy Biomedical Systems, Inc..

What is the FDA product code for Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor?

The FDA product code for Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor is DRT.

Related Clinical Trials

NCT06232876 Continuous Versus Intermittent Ward Monitoring NOT_YET_RECRUITING NCT01621594 Evaluating New Radiation Techniques for Cardiovascular Imaging RECRUITING NCT06172699 Assert-IQ Implantable Cardiac Monitor (ICM) Post Market Study COMPLETED NCT07405333 Effect of Coughing Exercises Versus Incentive Spirometry on Respiratory Function and Recovery in Children After Cardiac Surgery. RECRUITING NCT06589700 B2AD-Risk AFDAS Evolution of Burden of AF RECRUITING NCT03505801 Confirm Rx Insertable Cardiac Monitor SMART Registry COMPLETED

Related PubMed Literature

PMID: 41807277 QT Myopia and Cardiac Safety: Expanding the Aperture of Arrhythmia Assessment in Early Phase Drug Development. Clinical and translational science (2026) PMID: 40532100 Plasticizers Analysis in Extractables and Leachables by Gas Chromatography-Mass Spectrometry with Parallel Polyarc®/Flame Ionization Detector. Journal of chromatographic science (2025) PMID: 40415770 Use of cardiovascular registries in regulatory pathways: perspectives from the EU-MDR Cardiovascular Collaboratory. REC, interventional cardiology (2024) PMID: 40406702 Toward a unified gait freeze index: a standardized benchmark for clinical and regulatory evaluations. Frontiers in neurology (2025)

Other Devices by Ivy Biomedical Systems, Inc.

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Related Devices (Code: DRT)

K170828Cardiac Trigger MonitorIvy Biomedical Systems, Inc. K172586Vios Monitoring System™ Model 2050Vios Medical, Inc. K181165Philips wearable biosensor-G5 SolutionConnected Sensing- A Division of Philips Medical Systems K202138Cardiac Trigger MonitorIvy Biomedical Systems, Inc. K202464Vital Sign Monitoring Sensor (Model :XK300)Xandar Kardian, Inc. K212143Neteera 130H/131H Vital Sign Monitoring SensorNeteera Technologies , 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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