ALPHA 5000 WRIST 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 Alpha 5000 Wrist Coil.

Pre-market Notification Details

Device IDK031143
510k NumberK031143
Device Name:ALPHA 5000 WRIST 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 Received2003-04-10
Decision Date2003-05-29
Summary:summary

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