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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 K132059
Device Name DIAGNOSTIC ULTRASOUND SYSTEM
Applicant
Advanced Instrumentations, Inc.
601 W. 20th St.
Hialeah,  FL  33010
Applicant Contact JORGE MILLAN
Correspondent
Advanced Instrumentations, Inc.
601 W. 20th St.
Hialeah,  FL  33010
Correspondent Contact JORGE MILLAN
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received07/03/2013
Decision Date 10/25/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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