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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 K890913
Device Name SDU 800 DIAGNOSTIC ULTRASOUND INSTRUMENT
Applicant
Shimadzu Precision Instruments, Inc.
101 W. Walnut St.
Gardena,  CA  90248
Applicant Contact HIROJI KANAMORI
Correspondent
Shimadzu Precision Instruments, Inc.
101 W. Walnut St.
Gardena,  CA  90248
Correspondent Contact HIROJI KANAMORI
Regulation Number892.1560
Classification Product Code
IYO  
Date Received02/24/1989
Decision Date 09/06/1989
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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