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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 K910966
Device Name SECTOR TRANSDUCER MODEL NO. AWP3.5/A
Applicant
Kretztechnik AG
Tiefenbach 15
A-4871 Zipf
Austria,  AT
Applicant Contact DIETER KIRBACH
Correspondent
Kretztechnik AG
Tiefenbach 15
A-4871 Zipf
Austria,  AT
Correspondent Contact DIETER KIRBACH
Regulation Number892.1570
Classification Product Code
ITX  
Date Received03/06/1991
Decision Date 04/17/1992
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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