MODIFICATION TO PREMIER III PHASED ARRAY CTL SPINE 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 Modification To Premier Iii Phased Array Ctl Spine Coil.

Pre-market Notification Details

Device IDK031056
510k NumberK031056
Device Name:MODIFICATION TO PREMIER III PHASED ARRAY CTL SPINE 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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-04-03
Decision Date2003-05-08
Summary:summary

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