UNITY NETWORK ID

Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN

The following data is part of a premarket notification filed by General Electric Medical Systems Information Techn with the FDA for Unity Network Id.

Pre-market Notification Details

Device IDK021454
510k NumberK021454
Device Name:UNITY NETWORK ID
ClassificationMonitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Applicant GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN 8200 WEST TOWER AVE. Milwaukee,  WI  53223
ContactJoelle Neider
CorrespondentJoelle Neider
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN 8200 WEST TOWER AVE. Milwaukee,  WI  53223
Product CodeMWI  
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-05-06
Decision Date2002-10-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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00840682104630 K021454 000
00840682104623 K021454 000
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00840682104678 K021454 000
00840682104517 K021454 000

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