Ivy Biomedical Cardiac Trigger Monitor with EP Pulse Mode - HSA Registration DE0510571
Access comprehensive regulatory information for Ivy Biomedical Cardiac Trigger Monitor with EP Pulse Mode in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0510571 and owned by Ivy Biomedical systems, Inc.. The device was registered on April 10, 2025.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
The Ivy Biomedical Model 7600EP/7800EP is a basic cardiac monitor used to provide cardiac trigger pulse outputs used by third-party diagnostic imaging systems that require ECG synchronization, such as nuclear medicine, computed axial (CAT), or positron emission (PET) tomography, and other imaging systems requiring similar cardiac cycle specific timing. The Ivy Biomedical Model 7600EP/7800EP monitors can also be used to provide cardiac trigger pulse outputs used by third-party ablation and lithotripsy systems. The Model 7000 Series Cardiac Trigger Monitor is intended to perform ECG monitoring and R-wave pulse detection on adult, pediatric and neonatal patients. R-Wave synchronization is typically used for gating nuclear scanners, CT scanners, or other imaging devices.