MODELS EXL AND EXS EXTREMITY COIL SET

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 Models Exl And Exs Extremity Coil Set.

Pre-market Notification Details

Device IDK964668
510k NumberK964668
Device Name:MODELS EXL AND EXS EXTREMITY COIL SET
ClassificationCoil, Magnetic Resonance, Specialty
Applicant MRI DEVICES CORP. N8 W22520 JOHNSON DR., UNIT K JOHNSON DR., CORPORATE CENTER Waukesha,  WI  53186
ContactThomas Schubert
CorrespondentThomas Schubert
MRI DEVICES CORP. N8 W22520 JOHNSON DR., UNIT K JOHNSON DR., CORPORATE CENTER Waukesha,  WI  53186
Product CodeMOS  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-11-21
Decision Date1997-02-18

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884838085749 K964668 000

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