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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 K911107
Device Name SONARSCAN 128 ULTRASOUND SCANNER
Applicant
Diagnostic Sonar USA
67079 Read Rd.
Cambridge,  OH  43725
Applicant Contact BENNETT III
Correspondent
Diagnostic Sonar USA
67079 Read Rd.
Cambridge,  OH  43725
Correspondent Contact BENNETT III
Regulation Number892.1560
Classification Product Code
IYO  
Date Received03/12/1991
Decision Date 06/10/1991
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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