AIR Recon DL

System, Nuclear Magnetic Resonance Imaging

GE Medical Systems,LLC (GE Healthcare)

The following data is part of a premarket notification filed by Ge Medical Systems,llc (ge Healthcare) with the FDA for Air Recon Dl.

Pre-market Notification Details

Device IDK213717
510k NumberK213717
Device Name:AIR Recon DL
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant GE Medical Systems,LLC (GE Healthcare) 3200 N Grandview Blvd Waukesha,  WI  53188
ContactGlen Sabin
CorrespondentGlen Sabin
GE Medical Systems,LLC (GE Healthcare) 3200 N Grandview Blvd Waukesha,  WI  53188
Product CodeLNH  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-11-24
Decision Date2022-06-08

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