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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 K925434
Device Name SECTOR & TRANSVAGINAL MODEL #'S SW4/5B/A,EW5/7K/A
Applicant
Kretz Technik
Columbia Sq.
555 Thirteenth St., NW
Washington, D.C.,  DC  20004
Applicant Contact PATRICIA B SHRADER
Correspondent
Kretz Technik
Columbia Sq.
555 Thirteenth St., NW
Washington, D.C.,  DC  20004
Correspondent Contact PATRICIA B SHRADER
Regulation Number892.1570
Classification Product Code
ITX  
Date Received10/28/1992
Decision Date 09/30/1993
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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