CARDIAC VIEW, MODEL 2001

Coil, Magnetic Resonance, Specialty

MAGNA LAB, INC.

The following data is part of a premarket notification filed by Magna Lab, Inc. with the FDA for Cardiac View, Model 2001.

Pre-market Notification Details

Device IDK010802
510k NumberK010802
Device Name:CARDIAC VIEW, MODEL 2001
ClassificationCoil, Magnetic Resonance, Specialty
Applicant MAGNA LAB, INC. 150 CALIFORNIA ST. Newton,  MA  02458
ContactLynn Carter
CorrespondentLynn Carter
MAGNA LAB, INC. 150 CALIFORNIA ST. Newton,  MA  02458
Product CodeMOS  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-03-16
Decision Date2001-06-08

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