IVY Biomedical Cardiac Trigger Monitor - HSA Registration DE0011708
Access comprehensive regulatory information for IVY Biomedical Cardiac Trigger Monitor in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0011708 and owned by Ivy Biomedical Systems, Inc.. The device was registered on December 05, 2012.
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 3000 with T‐B option Cardiac Trigger Monitor is intended for monitoring the patient's ECG and Heart Rate. It is designed for use in the ICU, CCU and operating room conditions. It can sound an alarm when the HR falls outside of preset limits. It provides an output pulse, synchronized to the R‐wave for use in applications requiring precision R‐wave synchronization. The Model 3000 with T‐B option is limited to use by trained and qualified medical professionals. This product is not intended for home care monitoring.