6430 MyLabX75, 6430 MyLab XPro75

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 6430 Mylabx75, 6430 Mylab Xpro75.

Pre-market Notification Details

Device IDK212021
510k NumberK212021
Device Name:6430 MyLabX75, 6430 MyLab XPro75
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant Esaote S.p.A. Via Enrico Melen 77 Genoa,  IT 16152
ContactAlberto Carcagni
CorrespondentAlberto Carcagni
Esaote S.p.A. Via Enrico Melen 77 Genoa,  IT 16152
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-28
Decision Date2021-09-16

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08056304454386 K212021 000

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