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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 K000415
Device Name OIS-2500 DIAGNOSTIC ULTRASOUND SYSTEM
Applicant
Optimal Imaging Systems, Inc.
9344 NW 13th St.
Suite 200
Miami,  FL  33172
Applicant Contact JORGE MILLAN
Correspondent
Optimal Imaging Systems, Inc.
9344 NW 13th St.
Suite 200
Miami,  FL  33172
Correspondent Contact JORGE MILLAN
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Code
IYO  
Date Received02/08/2000
Decision Date 04/11/2000
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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