BRIVOXR285AMX, OPTIMA XR200AMX, OPTIMAXR220AMX

System, X-ray, Mobile

GE MEDICAL SYSTEMS, LLC

The following data is part of a premarket notification filed by Ge Medical Systems, Llc with the FDA for Brivoxr285amx, Optima Xr200amx, Optimaxr220amx.

Pre-market Notification Details

Device IDK103476
510k NumberK103476
Device Name:BRIVOXR285AMX, OPTIMA XR200AMX, OPTIMAXR220AMX
ClassificationSystem, X-ray, Mobile
Applicant GE MEDICAL SYSTEMS, LLC 3000 N GRANDVIEW BLVD. Waukesha,  WI  53188
ContactNidhi Chaudhary
CorrespondentNidhi Chaudhary
GE MEDICAL SYSTEMS, LLC 3000 N GRANDVIEW BLVD. Waukesha,  WI  53188
Product CodeIZL  
CFR Regulation Number892.1720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-11-24
Decision Date2011-06-16
Summary:summary

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