Unity Network ID

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

GE Healthcare

The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Unity Network Id.

Pre-market Notification Details

Device IDK170199
510k NumberK170199
Device Name:Unity Network ID
ClassificationMonitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Applicant GE Healthcare 8200 West Tower Ave. Milwaukee,  WI  53223
ContactRobert Casarsa
CorrespondentRobert Casarsa
GE Healthcare 8200 West Tower Ave. Milwaukee,  WI  53223
Product CodeMWI  
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-01-23
Decision Date2017-05-12
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.