REVOLUTION CT

System, X-ray, Tomography, Computed

GE MEDICAL SYSTEMS, LLC

The following data is part of a premarket notification filed by Ge Medical Systems, Llc with the FDA for Revolution Ct.

Pre-market Notification Details

Device IDK133705
510k NumberK133705
Device Name:REVOLUTION CT
ClassificationSystem, X-ray, Tomography, Computed
Applicant GE MEDICAL SYSTEMS, LLC 3000 N GRANDVIEW BLVD. Waukesha,  WI  53188
ContactHelen Peng
CorrespondentHelen Peng
GE MEDICAL SYSTEMS, LLC 3000 N GRANDVIEW BLVD. Waukesha,  WI  53188
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-12-03
Decision Date2014-04-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840682140713 K133705 000

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