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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Ultrasonic, Obstetric
510(k) Number K771151
Device Name ARTIUS SYSTEM
Applicant
GENERAL ELECTRIC CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
GENERAL ELECTRIC CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number884.2960
Classification Product Code
HGL  
Date Received06/24/1977
Decision Date 08/04/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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