MYLABSEVEN, MYLABALPHA

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 Mylabseven, Mylabalpha.

Pre-market Notification Details

Device IDK142008
510k NumberK142008
Device Name:MYLABSEVEN, MYLABALPHA
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant ESAOTE S.P.A. 9001 Wesleyan Road, Suite 200 Indianapolis,  IN  46268
ContactAllison Scott
CorrespondentAllison Scott
ESAOTE S.P.A. 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 Received2014-07-23
Decision Date2014-09-12
Summary:summary

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