6420 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 6420 Ultrasound System.

Pre-market Notification Details

Device IDK183191
510k NumberK183191
Device Name:6420 Ultrasound System
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant Esaote, S.p.A. Via Enrico Melen 77 Genova,  IT 16152
ContactMassimo Polignano
CorrespondentAllison Scott
Navigant 9100 Keystone Crossing, Suite 500 Indianapolis,  IN  46240
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-11-19
Decision Date2018-12-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08056304453563 K183191 000

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