MAC 800 Resting ECG Analysis System

Electrocardiograph

GE MEDICAL SYSTEMS CHINA CO., LTD.

The following data is part of a premarket notification filed by Ge Medical Systems China Co., Ltd. with the FDA for Mac 800 Resting Ecg Analysis System.

Pre-market Notification Details

Device IDK142288
510k NumberK142288
Device Name:MAC 800 Resting ECG Analysis System
ClassificationElectrocardiograph
Applicant GE MEDICAL SYSTEMS CHINA CO., LTD. NO. 19 CHANGJIANG ROAD, NATIONAL HI-TECH DEV. ZONE NATIONAL HI-TECH DEV. ZONE Wuxi,  CN 214028
ContactSun Yanli
CorrespondentKristin Pabst
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 9900 WEST INNOVATION DR. Wauwatosa,  WI  53226
Product CodeDPS  
CFR Regulation Number870.2340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-08-18
Decision Date2014-12-03
Summary:summary

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