MODIFICATION TO HRW-127 WRIST ARRAY COIL

Coil, Magnetic Resonance, Specialty

MRI DEVICES CORP.

The following data is part of a premarket notification filed by Mri Devices Corp. with the FDA for Modification To Hrw-127 Wrist Array Coil.

Pre-market Notification Details

Device IDK040349
510k NumberK040349
Device Name:MODIFICATION TO HRW-127 WRIST ARRAY COIL
ClassificationCoil, Magnetic Resonance, Specialty
Applicant MRI DEVICES CORP. 1515 PARAMOUNT DR. Waukesha,  WI  53186
ContactThomas Schubert
CorrespondentThomas Schubert
MRI DEVICES CORP. 1515 PARAMOUNT DR. Waukesha,  WI  53186
Product CodeMOS  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-02-12
Decision Date2004-03-09

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