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 Premier Iii Phased Array Ctl Spine Coil.

Pre-market Notification Details

Device IDK013595
510k NumberK013595
Device Name:PREMIER III PHASED ARRAY CTL SPINE COIL
ClassificationCoil, Magnetic Resonance, Specialty
Applicant USA INSTRUMENTS, INC. 1515 DANNER DR. Aurora,  OH  44202
ContactRony Thomas
CorrespondentRony Thomas
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 Received2001-10-30
Decision Date2002-01-22
Summary:summary

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