MYLAB40

Transducer, Ultrasonic, Diagnostic

ESAOTE EUROPE B.V.

The following data is part of a premarket notification filed by Esaote Europe B.v. with the FDA for Mylab40.

Pre-market Notification Details

Device IDK070903
510k NumberK070903
Device Name:MYLAB40
ClassificationTransducer, Ultrasonic, Diagnostic
Applicant ESAOTE EUROPE B.V. 11460 N. MERIDIAN STREET SUITE 150 Carmel,  IN  46032
ContactCarri Graham
CorrespondentCarri Graham
ESAOTE EUROPE B.V. 11460 N. MERIDIAN STREET SUITE 150 Carmel,  IN  46032
Product CodeITX  
Subsequent Product CodeIYN
Subsequent Product CodeIYO
CFR Regulation Number892.1570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-04-02
Decision Date2007-07-02
Summary:summary

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