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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 Echo, Ultrasonic
510(k) Number K955543
Device Name ULTRASOUND SYSTEM MODEL UF-3500
Applicant
Fukuda Denshi USA, Inc.
7102 180th.Ave. Nebldg.A-
Suite 101
Redmond,  WA  98052
Applicant Contact DAVID J GERAGHTY
Correspondent
Fukuda Denshi USA, Inc.
7102 180th.Ave. Nebldg.A-
Suite 101
Redmond,  WA  98052
Correspondent Contact DAVID J GERAGHTY
Regulation Number892.1560
Classification Product Code
IYO  
Date Received12/05/1995
Decision Date 02/11/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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