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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 K020668
Device Name ALOKA SSD-1000 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS ASU-1003, UST-9121, UST-9124
Applicant
Aloka Co., Ltd.
10 Fairfield Blvd.
Wallingford,  CT  06492
Applicant Contact KELVIN BURROUGHS
Correspondent
Aloka Co., Ltd.
10 Fairfield Blvd.
Wallingford,  CT  06492
Correspondent Contact KELVIN BURROUGHS
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received03/01/2002
Decision Date 07/10/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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