Ivy Biomedical Cardiac Trigger Monitor with EP Pulse Mode
- 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
- Risk class
- Class C
- Product owner
- Ivy Biomedical systems, Inc.
- Registrant / registration holder
- EMERGO SINGAPORE CONSULTING PRIVATE LIMITED
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.
- 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
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.