SPIRIT III TOTALSENSE CARDIAC COIL

Coil, Magnetic Resonance, Specialty

USA INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Usa Instruments, Inc. with the FDA for Spirit Iii Totalsense Cardiac Coil.

Pre-market Notification Details

Device IDK024187
510k NumberK024187
Device Name:SPIRIT III TOTALSENSE CARDIAC COIL
ClassificationCoil, Magnetic Resonance, Specialty
Applicant USA INSTRUMENTS, INC. 1515 DANNER DR. Aurora,  OH  44202
ContactChristie Shumaker
CorrespondentChristie Shumaker
USA INSTRUMENTS, INC. 1515 DANNER DR. Aurora,  OH  44202
Product CodeMOS  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-12-19
Decision Date2003-02-04
Summary:summary

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