PHASED ARRAY KNEE AND FOOT 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 Phased Array Knee And Foot Coil.

Pre-market Notification Details

Device IDK994040
510k NumberK994040
Device Name:PHASED ARRAY KNEE AND FOOT 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 Received1999-11-29
Decision Date2000-01-18
Summary:summary

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