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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 K896644
Device Name ADDITIONAL TRANSDUCERS FOR USE WITH SDU 500
Applicant
Shimadzu Corp.
101 W. Walnut St.
Gardena,  CA  90248
Applicant Contact HIROJI KANAMORI
Correspondent
Shimadzu Corp.
101 W. Walnut St.
Gardena,  CA  90248
Correspondent Contact HIROJI KANAMORI
Regulation Number892.1570
Classification Product Code
ITX  
Date Received11/24/1989
Decision Date 08/21/1990
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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