ARGUS PET SYSTEM

System, Tomography, Computed, Emission

GE MEDICAL SYSTEMS

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

Pre-market Notification Details

Device IDK923309
510k NumberK923309
Device Name:ARGUS PET SYSTEM
ClassificationSystem, Tomography, Computed, Emission
Applicant GE MEDICAL SYSTEMS 3000 N GRANDVIEW BLVD. W-709 Waukesha,  WI  53188
ContactLarry A Kroger
CorrespondentLarry A Kroger
GE MEDICAL SYSTEMS 3000 N GRANDVIEW BLVD. W-709 Waukesha,  WI  53188
Product CodeKPS  
CFR Regulation Number892.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-07-07
Decision Date1992-09-29

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