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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 K983691
Device Name SCANFLEX SOLID COUPLANT MEMBRANE
Applicant
Sonotech, Inc.
P.O. Box 10489
State College,  PA  16805
Applicant Contact MARGARET J LARSON
Correspondent
Sonotech, Inc.
P.O. Box 10489
State College,  PA  16805
Correspondent Contact MARGARET J LARSON
Regulation Number892.1570
Classification Product Code
ITX  
Date Received10/20/1998
Decision Date 05/05/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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