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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 K943637
Device Name SSD-2000 DIAGNOSTIC ULTRASOUND SYSTEM
Applicant
Aloka Co., Ltd.
10 Fairfield Blvd.
Wallingford,  CT  06492
Applicant Contact PAUL D SMOLENSKI
Correspondent
Aloka Co., Ltd.
10 Fairfield Blvd.
Wallingford,  CT  06492
Correspondent Contact PAUL D SMOLENSKI
Regulation Number892.1570
Classification Product Code
ITX  
Subsequent Product Code
IYN  
Date Received07/27/1994
Decision Date 12/29/1994
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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