6450 Ultrasound System

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 6450 Ultrasound System.

Pre-market Notification Details

Device IDK192157
501k NumberK192157
Device Name:6450 Ultrasound System
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant Esaote, S.p.A. Via E Melen 77 Genoa,  IT 16152
ContactPiet Dejong
CorrespondentPiet Dejong
Esaote, S.p.A. Via E Melen 77 Genoa,  IT 16152
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyRadiology
501k Review PanelRadiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-09
Decision Date2019-11-22

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