S-SCAN, MODEL 9800020010

Coil, Magnetic Resonance, Specialty

ESAOTE, S.P.A.

The following data is part of a premarket notification filed by Esaote, S.p.a. with the FDA for S-scan, Model 9800020010.

Pre-market Notification Details

Device IDK100670
510k NumberK100670
Device Name:S-SCAN, MODEL 9800020010
ClassificationCoil, Magnetic Resonance, Specialty
Applicant ESAOTE, S.P.A. 11460 N MERIDIAN ST., STE 150 Carmel,  IN  46032
ContactAllison Scott
CorrespondentAllison Scott
ESAOTE, S.P.A. 11460 N MERIDIAN ST., STE 150 Carmel,  IN  46032
Product CodeMOS  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-03-09
Decision Date2010-04-05
Summary:summary

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