6400 Ultrasound System,7400 Ultrasound System, 7410 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 6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System.

Pre-market Notification Details

Device IDK161359
510k NumberK161359
Device Name:6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant Esaote S.p.A Via A. Siffredi 58 Genova,  IT 16153
ContactMassimo Polignano
CorrespondentAllison Scott
Navigant Consulting, Inc 9001 Wesleyan Road, Suite 200 Indianapolis,  IN  46268
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-05-16
Decision Date2016-07-19
Summary:summary

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