CARESCAPE V100

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

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES

The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies with the FDA for Carescape V100.

Pre-market Notification Details

Device IDK073203
510k NumberK073203
Device Name:CARESCAPE V100
ClassificationMonitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Applicant GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 4502 WOODLAND CORP.BLVD. Tampa,  FL  33614
ContactKaren Russell
CorrespondentKaren Russell
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 4502 WOODLAND CORP.BLVD. Tampa,  FL  33614
Product CodeMHX  
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-11-13
Decision Date2007-11-29
Summary:summary

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