6440 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 6440 Ultrasound System.

Pre-market Notification Details

Device IDK173291
510k NumberK173291
Device Name:6440 Ultrasound System
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant Esaote S.p.A Via Enrico Melen 77 Genova,  IT 16152
ContactMassimo Polignano
CorrespondentAllison Scott
Navigant Consulting, Inc 9100 Keystone Crossing Suite 500 Indianapolis,  IN  46240
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-10-16
Decision Date2018-01-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08056304453921 K173291 000
08056304454676 K173291 000

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