TECHNOS MP, MODEL AU6

System, Imaging, Pulsed Doppler, Ultrasonic

BIOSOUND ESAOTE, INC.

The following data is part of a premarket notification filed by Biosound Esaote, Inc. with the FDA for Technos Mp, Model Au6.

Pre-market Notification Details

Device IDK023255
510k NumberK023255
Device Name:TECHNOS MP, MODEL AU6
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant BIOSOUND ESAOTE, INC. 8000 CASTLEWAY DR. Indianapolis,  IN  46250
ContactColleen Hittle Densmore
CorrespondentColleen Hittle Densmore
BIOSOUND ESAOTE, INC. 8000 CASTLEWAY DR. Indianapolis,  IN  46250
Product CodeIYN  
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-09-30
Decision Date2003-02-11
Summary:summary

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