CARESCAPE ONE And CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRES

Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

GE Healthcare

The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Carescape One And Carescape Dock Fo, Carescape Ecg, Carescape Temp, Carescape Pres.

Pre-market Notification Details

Device IDK200494
510k NumberK200494
Device Name:CARESCAPE ONE And CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRES
ClassificationMonitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Applicant GE Healthcare 8200 West Tower Avenue Milwaukee,  WI  53223
ContactJoel Kent
CorrespondentJoel Kent
GE Healthcare 8200 West Tower Avenue Milwaukee,  WI  53223
Product CodeMHX  
Subsequent Product CodeBZQ
Subsequent Product CodeCAR
Subsequent Product CodeDPZ
Subsequent Product CodeDQA
Subsequent Product CodeDRT
Subsequent Product CodeDSI
Subsequent Product CodeDSJ
Subsequent Product CodeDSK
Subsequent Product CodeDXN
Subsequent Product CodeFLL
Subsequent Product CodeMLD
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-28
Decision Date2020-03-29

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840682123976 K200494 000
00840682123969 K200494 000
00840682123952 K200494 000
00840682123921 K200494 000
00840682124799 K200494 000
00840682124607 K200494 000
00840682125901 K200494 000

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