PATIENT MONITOR, MODELS DASH 3000, 4000 AND 5000

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 Patient Monitor, Models Dash 3000, 4000 And 5000.

Pre-market Notification Details

Device IDK051367
510k NumberK051367
Device Name:PATIENT MONITOR, MODELS DASH 3000, 4000 AND 5000
ClassificationMonitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Applicant GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 4502 WOODLAND CORPORATE BLVD. Tampa,  FL  33614
ContactTyler Sedone
CorrespondentTyler Sedone
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 4502 WOODLAND CORPORATE BLVD. Tampa,  FL  33614
Product CodeMHX  
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-05-25
Decision Date2005-06-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840682103084 K051367 000
00840682103060 K051367 000

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