MYLABFIVE

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 Mylabfive.

Pre-market Notification Details

Device IDK083882
510k NumberK083882
Device Name:MYLABFIVE
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant ESAOTE EUROPE B.V. 11460 N. MERIDIAN STREET SUITE 150 Carmel,  IN  46032
ContactJamie Austin
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2008-12-29
Decision Date2009-01-30
Summary:summary

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