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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: E12 Electrocardiograph; E3 Electrocardiograph; ECG100G Electrocardiograph; ECG1200G Electrocardiograph; ECG1212G Electrocardiograph; ECG300G Electrocardiograph
Classification Name: ELECTROCARDIOGRAPH
Product Code: DPS
Device Class: 2
Regulation Number: 870.2340
Medical Specialty: Cardiovascular
Registered Establishment Name: CONTEC MEDICAL SYSTEMS CO., LTD
Registered Establishment Number: 3006979678
Premarket Submission Number: K131900
Owner/Operator: CONTEC MEDICAL SYSTEMS CO., LTD
Owner/Operator Number: 10025156
Establishment Operations: Manufacturer
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