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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 K894763
Device Name FUJINON EDU SYSTEM
Applicant
Fujinon, Inc.
Suite 750
2001 L St., NW
Washington,  DC  20036
Applicant Contact MATTHEW J MARKS
Correspondent
Fujinon, Inc.
Suite 750
2001 L St., NW
Washington,  DC  20036
Correspondent Contact MATTHEW J MARKS
Regulation Number892.1570
Classification Product Code
ITX  
Date Received07/27/1989
Decision Date 05/22/1990
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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