EUB-5500 DIAGNOSTIC ULTRASOUND SCANNER

System, Imaging, Pulsed Doppler, Ultrasonic

HITACHI MEDICAL SYSTEMS AMERICA, INC.

The following data is part of a premarket notification filed by Hitachi Medical Systems America, Inc. with the FDA for Eub-5500 Diagnostic Ultrasound Scanner.

Pre-market Notification Details

Device IDK032503
510k NumberK032503
Device Name:EUB-5500 DIAGNOSTIC ULTRASOUND SCANNER
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant HITACHI MEDICAL SYSTEMS AMERICA, INC. 1959 SUMMIT COMMERCE PARK Twinsburg,  OH  44087
ContactDoug Thistlethwaite
CorrespondentDoug Thistlethwaite
HITACHI MEDICAL SYSTEMS AMERICA, INC. 1959 SUMMIT COMMERCE PARK Twinsburg,  OH  44087
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-08-13
Decision Date2003-08-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04961333243068 K032503 000

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