MODIFICATION TO E-SCAN

System, Nuclear Magnetic Resonance Imaging

BIOSOUND ESAOTE, INC.

The following data is part of a premarket notification filed by Biosound Esaote, Inc. with the FDA for Modification To E-scan.

Pre-market Notification Details

Device IDK001894
510k NumberK001894
Device Name:MODIFICATION TO E-SCAN
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant BIOSOUND ESAOTE, INC. 8000 CASTLEWAY DR. Indianapolis,  IN  46250
ContactColleen Hittle
CorrespondentColleen Hittle
BIOSOUND ESAOTE, INC. 8000 CASTLEWAY DR. Indianapolis,  IN  46250
Product CodeLNH  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-06-21
Decision Date2000-07-06

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