MAGNETIC RESONANCE DIAGNOSTIC SYSTEM

System, Nuclear Magnetic Resonance Imaging

GE MEDICAL SYSTEMS

The following data is part of a premarket notification filed by Ge Medical Systems with the FDA for Magnetic Resonance Diagnostic System.

Pre-market Notification Details

Device IDK950973
510k NumberK950973
Device Name:MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant GE MEDICAL SYSTEMS 3000 N. GRANDVIEW BLVD. Waukesha,  WI  53188
ContactLarry A Kroger
CorrespondentLarry A Kroger
GE MEDICAL SYSTEMS 3000 N. GRANDVIEW BLVD. Waukesha,  WI  53188
Product CodeLNH  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-03-02
Decision Date1995-05-11
Summary:summary

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