1.5T AND 3T 8-CHANNEL MEDIUM GENERAL PURPOSE FLEX COIL

Coil, Magnetic Resonance, Specialty

INVIVO CORPORATION

The following data is part of a premarket notification filed by Invivo Corporation with the FDA for 1.5t And 3t 8-channel Medium General Purpose Flex Coil.

Pre-market Notification Details

Device IDK111673
510k NumberK111673
Device Name:1.5T AND 3T 8-CHANNEL MEDIUM GENERAL PURPOSE FLEX COIL
ClassificationCoil, Magnetic Resonance, Specialty
Applicant INVIVO CORPORATION 3545 S.W. 47TH AVE. Gainesville,  FL  32608
ContactElizabeth Wheeler
CorrespondentElizabeth Wheeler
INVIVO CORPORATION 3545 S.W. 47TH AVE. Gainesville,  FL  32608
Product CodeMOS  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-06-15
Decision Date2011-12-23
Summary:summary

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