MYLAB30, 50 AND 70 SYSTEMS UPGRADE, MODELS 7300, 7350, 6150

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 Mylab30, 50 And 70 Systems Upgrade, Models 7300, 7350, 6150.

Pre-market Notification Details

Device IDK052805
510k NumberK052805
Device Name:MYLAB30, 50 AND 70 SYSTEMS UPGRADE, MODELS 7300, 7350, 6150
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant ESAOTE S.P.A. 7992 CASTLEWAY DRIVE Indianapolis,  IN  46250
ContactCarri Graham
CorrespondentCarri Graham
ESAOTE S.P.A. 7992 CASTLEWAY DRIVE Indianapolis,  IN  46250
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-10-04
Decision Date2005-10-17
Summary:summary

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