MYLABGOLD

System, Imaging, Pulsed Echo, Ultrasonic

ESAOTE

The following data is part of a premarket notification filed by Esaote with the FDA for Mylabgold.

Pre-market Notification Details

Device IDK110688
510k NumberK110688
Device Name:MYLABGOLD
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant ESAOTE 11460 N. MERIDIAN ST., STE. 150 Carmel,  IN  46032
ContactAllison Scott
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeIYO  
Subsequent Product CodeITX
Subsequent Product CodeIYN
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2011-03-11
Decision Date2011-06-02
Summary:summary

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