Transcription of NOV 2 4 2003 - Food and Drug Administration
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NOV 2 4 2003 51 O(k) Summary of Safety and Effectiveness Date: October 30, 2003 Submitter: GE Medical Systems - lnformation Technologies 8200 W. Tower Ave. Milwaukee, WI 53223 USA Contact Person: Lisa Lee Michels GE Medical Systems - lnformation Technologies Phone: (262) 293-1609 Fax: (414) 918-8203 Contact Person: David Wahlig GE Medical Systems - lnformafion Technologies Phone: (262) 293-1 705 Fax: (414) 918-81 12 TradelProprietarv Name: MAC 5000 ECG Analysis system CommonlUsual Name: Electrocardiograph Classification Names & Citations.
The MAC 5000 ECG Analysis System is intended to acquire, analyze, display, and record electrocardiographic information from adult and pediatric populations. Basic systems
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