7350 ULTRASOUND IMAGING SYSTEM, MODEL 7350

System, Imaging, Pulsed Doppler, Ultrasonic

ESAOTE, S.P.A.

The following data is part of a premarket notification filed by Esaote, S.p.a. with the FDA for 7350 Ultrasound Imaging System, Model 7350.

Pre-market Notification Details

Device IDK050326
510k NumberK050326
Device Name:7350 ULTRASOUND IMAGING SYSTEM, MODEL 7350
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant ESAOTE, S.P.A. 7992 CASTLEWAY DRIVE Indianapolis,  IN  46250
ContactCarri Graham
CorrespondentCarri Graham
ESAOTE, S.P.A. 7992 CASTLEWAY DRIVE Indianapolis,  IN  46250
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-02-09
Decision Date2005-02-28
Summary:summary

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