MyLabSix Ultrasound System

System, Imaging, Pulsed Doppler, Ultrasonic

Esaote Europe B.V.

The following data is part of a premarket notification filed by Esaote Europe B.v. with the FDA for Mylabsix Ultrasound System.

Pre-market Notification Details

Device IDK161168
510k NumberK161168
Device Name:MyLabSix Ultrasound System
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant Esaote Europe B.V. Philipsweg 1 Maastricht,  NL 6227 Aj
ContactBert Vorstenbosch
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 Received2016-04-26
Decision Date2016-09-02
Summary:summary

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