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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 K925646
Device Name SSD-2000 DIAG. ULTRASOUND SYS.&UST-979-3.5 TRANS.
Applicant
Aloka Co., Ltd.
10 Fairfield Blvd.
Wallingford,  CT  06492
Applicant Contact CAROL BENNETT
Correspondent
Aloka Co., Ltd.
10 Fairfield Blvd.
Wallingford,  CT  06492
Correspondent Contact CAROL BENNETT
Regulation Number892.1560
Classification Product Code
IYO  
Date Received11/09/1992
Decision Date 02/12/1993
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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