CARESCAPE CENTRAL STATION (FORMALLY KNOWN AS CIC PRO)

Display, Cathode-ray Tube, Medical

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies, Inc. with the FDA for Carescape Central Station (formally Known As Cic Pro).

Pre-market Notification Details

Device IDK133882
510k NumberK133882
Device Name:CARESCAPE CENTRAL STATION (FORMALLY KNOWN AS CIC PRO)
ClassificationDisplay, Cathode-ray Tube, Medical
Applicant GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. 8200 WEST TOWER AVE. Milwaukee,  WI  53223
ContactRobert Casarsa
CorrespondentRobert Casarsa
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. 8200 WEST TOWER AVE. Milwaukee,  WI  53223
Product CodeDXJ  
Subsequent Product CodeBSE
Subsequent Product CodeBZQ
Subsequent Product CodeCBQ
Subsequent Product CodeCBR
Subsequent Product CodeCBS
Subsequent Product CodeCCI
Subsequent Product CodeCCK
Subsequent Product CodeCCL
Subsequent Product CodeDOA
Subsequent Product CodeDPT
Subsequent Product CodeDSB
Subsequent Product CodeDSK
Subsequent Product CodeDXN
Subsequent Product CodeFLL
Subsequent Product CodeGWQ
Subsequent Product CodeJEG
Subsequent Product CodeNHO
Subsequent Product CodeNHP
Subsequent Product CodeNHQ
Subsequent Product Code&nb
CFR Regulation Number870.2450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-12-20
Decision Date2014-04-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840682109833 K133882 000
00840682109826 K133882 000

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