GE MAC 800 Resting ECG analysis system - HSA Registration DE0008938
Access comprehensive regulatory information for GE MAC 800 Resting 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 DE0008938 and owned by GE Medical Systems (China) Co., Ltd.. The device was registered on March 22, 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 MAC 800 Resting ECG Analysis System is a portable ECG acquisition, analysis and recording system intended to: acquire, analyze, display, and record information from adult and pediatric populations; be used under the direct supervision of a licensed health care practitioner;be used by trained operators in a hospital or medical professional’s facility environment, as well as used in clinics, physician offices, outreach centers;offer two basic modes of operation: (1) resting ECG mode and (2) arrhythmia mode; print 3- and 6 leads of ECG; be upgradeable to provide software options such as 12-lead ECG measurement and interpretive analysis, provide for the optional transmission and reception of ECG data to and from a central ECG cardiovascular information system.