MODEL 472GE-128: QUADRATURE LOWER EXTREMITY COIL

Coil, Magnetic Resonance, Specialty

MEDICAL ADVANCES, INC.

The following data is part of a premarket notification filed by Medical Advances, Inc. with the FDA for Model 472ge-128: Quadrature Lower Extremity Coil.

Pre-market Notification Details

Device IDK023084
510k NumberK023084
Device Name:MODEL 472GE-128: QUADRATURE LOWER EXTREMITY COIL
ClassificationCoil, Magnetic Resonance, Specialty
Applicant MEDICAL ADVANCES, INC. 10437 INNOVATION DR. Milwaukee,  WI  53226
ContactAnthony Dietzler
CorrespondentAnthony Dietzler
MEDICAL ADVANCES, INC. 10437 INNOVATION DR. Milwaukee,  WI  53226
Product CodeMOS  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-09-17
Decision Date2002-12-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884838067127 K023084 000
00884838066229 K023084 000

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