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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, Diagnostic
510(k) Number K141093
Device Name 6VT-D ULTRASOUND TRANSDUCER
Applicant
Ge Vingmed Ultrasound AS
Strandpromenaden 45
Horten,  NO N-3183
Applicant Contact BRYAN BEHN
Correspondent
Ge Vingmed Ultrasound AS
Strandpromenaden 45
Horten,  NO N-3183
Correspondent Contact BRYAN BEHN
Regulation Number892.1570
Classification Product Code
ITX  
Date Received04/28/2014
Decision Date 05/15/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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