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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 K961692
Device Name SONOSCAN
Applicant
Sonotech, Inc.
1413 Fraser St.
Bldg. H, Suite 102
Bellingham,  WA  98226
Applicant Contact MARGARET J LARSON
Correspondent
Sonotech, Inc.
1413 Fraser St.
Bldg. H, Suite 102
Bellingham,  WA  98226
Correspondent Contact MARGARET J LARSON
Regulation Number892.1570
Classification Product Code
ITX  
Date Received05/01/1996
Decision Date 08/22/1996
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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