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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 Doppler, Ultrasonic
510(k) Number K012080
Device Name SSD-5000 DIAGNOSTIC ULTRASOUND SYSTEM
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 Number892.1550
Classification Product Code
IYN  
Subsequent Product Code
IYO  
Date Received07/03/2001
Decision Date 08/29/2001
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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