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HSA · registration DE0510571

Ivy Biomedical Cardiac Trigger Monitor with EP Pulse Mode

SingaporeCardiovascularClass CIvy Biomedical systems, Inc.
Official record identity
Registration number
DE0510571
Model name
ECG Lead Wires, 4-Lead Set, Metallic, AHA, 36in; ECG Truck Cable, 4-Lead, Shielded, AHA/IEC, 10ft; AccuScan-EG Radiotranslucent ECG Electrodes; Cardiac Trigger Monitor 7600EP; Cardiac Trigger Monitor 7800EP
Model identifier
590445; 590478; 590494; 7600EP; 7800EP
Registration date
April 10, 2025
Classification
Risk class
Class C
Official value: CLASS C
Published category
Cardiovascular
Published parties
Registrant / registration holder
EMERGO SINGAPORE CONSULTING PRIVATE LIMITED
Official description

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.

Additional source fields
Product owner address
11 Business Park Drive, Branford, Connecticut, 06405, United States
Registrant address
1 HARBOURFRONT PLACE, #11-01-03, HARBOURFRONT TOWER ONE, Singapore 098633
About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.