MILLENNIUM III 4 CHANNEL NEUROVASCULAR 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 Millennium Iii 4 Channel Neurovascular Coil.

Pre-market Notification Details

Device IDK032415
510k NumberK032415
Device Name:MILLENNIUM III 4 CHANNEL NEUROVASCULAR 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 Received2003-08-05
Decision Date2003-08-25
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.