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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 Doppler, Ultrasonic
510(k) Number K945957
Device Name AUSONICS OPUS 2 REALTIME ULTRASOUND SCANNER
Applicant
Kleinfeld, Kaplan and Becker
1140 Nineteenth St., NW
Washington,  DC  20036
Applicant Contact RICHARD S MOREY
Correspondent
Kleinfeld, Kaplan and Becker
1140 Nineteenth St., NW
Washington,  DC  20036
Correspondent Contact RICHARD S MOREY
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received12/06/1994
Decision Date 04/15/1996
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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