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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 K110266
Device Name MAC 5500 HD, MAC 3500
Applicant
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC
9900 INOVATION DRIVE
WAUWATOSA,  WI  53226
Applicant Contact PATRICIA TAIGE
Correspondent
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC
9900 INOVATION DRIVE
WAUWATOSA,  WI  53226
Correspondent Contact PATRICIA TAIGE
Regulation Number870.2340
Classification Product Code
DPS  
Subsequent Product Codes
DQK   DXH  
Date Received01/28/2011
Decision Date 04/29/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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