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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrocardiograph
510(k) Number K090212
Device Name MAC 800 RESTING ECG ANALYSIS SYSTEM
Applicant
GE MEDICAL SYST. INFORMATION TECHNOLOGIES
9900 Innovation Drive
Wauwatosa,  WI  53226
Applicant Contact LARRY LEPLEY
Correspondent
GE MEDICAL SYST. INFORMATION TECHNOLOGIES
9900 Innovation Drive
Wauwatosa,  WI  53226
Correspondent Contact LARRY LEPLEY
Regulation Number870.2340
Classification Product Code
DPS  
Subsequent Product Code
DQK  
Date Received01/28/2009
Decision Date 02/19/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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