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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 K142288
Device Name MAC 800 Resting ECG Analysis System
Applicant
GE MEDICAL SYSTEMS CHINA CO., LTD.
NO. 19 CHANGJIANG ROAD, NATIONAL HI-TECH DEV. ZONE
NATIONAL HI-TECH DEV. ZONE
WUXI,  CN 214028
Applicant Contact Sun YanLi
Correspondent
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
9900 WEST INNOVATION DR.
WAUWATOSA,  WI  53226
Correspondent Contact KRISTIN PABST
Regulation Number870.2340
Classification Product Code
DPS  
Date Received08/18/2014
Decision Date 12/03/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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