DUS-7000 Digital Color Doppler Ultrasound System

System, Imaging, Pulsed Doppler, Ultrasonic

Advanced Instrumentations, Inc

The following data is part of a premarket notification filed by Advanced Instrumentations, Inc with the FDA for Dus-7000 Digital Color Doppler Ultrasound System.

Pre-market Notification Details

Device IDK172055
510k NumberK172055
Device Name:DUS-7000 Digital Color Doppler Ultrasound System
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant Advanced Instrumentations, Inc 6800 NW 77th Ct Miami,  FL  33166
ContactJorge Millan
CorrespondentJorge Millan
Advanced Instrumentations, Inc 6800 NW 77th Ct Miami,  FL  33166
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-07-06
Decision Date2017-08-31

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