GE MACi ECG Analysis System - HSA Registration DE0009491
Access comprehensive regulatory information for GE MACi ECG Analysis System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0009491 and owned by GE Medical Systems Information Technologies. The device was registered on August 14, 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.
1. MACi is intended to be an ECG acquisition, analysis and recording system. 2. MACi is intended for use under the direct supervision of a licensed healthcare practitioner. 3. Trained operators in small and medium hospitals will use MACi to record ECG signals from surface electrodes. 4. MACi is intended to acquire, record and measure electrocardiogram information from adult and pediatric populations. 5. The basic system delivers 12 leads ECG in print. 6. MACi is not intended for use as a vital signs physiological monitor. 7. MACi is not intended for use during patient transport. 8. MACi is not intended for intra cardiac application.