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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K844393
Device Name GL ULTRASOUND SECTOR 170
Applicant
Gl Ultrasound , Ltd.
1 Adam Sq.
Livingston W.Lothian,  GB
Applicant Contact GEORGE BOWIE
Correspondent
Gl Ultrasound , Ltd.
1 Adam Sq.
Livingston W.Lothian,  GB
Correspondent Contact GEORGE BOWIE
Regulation Number892.1560
Classification Product Code
IYO  
Date Received11/13/1984
Decision Date 04/10/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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