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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 K926108
Device Name VINGMED SOUND COLOR FLOW MAPPING SYSTEM, CFM-800
Applicant
Vingmed Sound, Inc.
P.O. Box 141
Horten,  NO N-3191
Applicant Contact KORN HEIDE
Correspondent
Vingmed Sound, Inc.
P.O. Box 141
Horten,  NO N-3191
Correspondent Contact KORN HEIDE
Regulation Number892.1570
Classification Product Code
ITX  
Date Received12/03/1992
Decision Date 09/24/1993
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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