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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
510(k) Number K183116
Device Name Unity Network ID
Applicant
GE Healthcare
8200 W. Tower Ave.
Milwaukee,  WI  53223
Applicant Contact Brandon O'Shea
Correspondent
GE Healthcare
8200 W. Tower Ave.
Milwaukee,  WI  53223
Correspondent Contact Brandon O'Shea
Regulation Number870.2300
Classification Product Code
MWI  
Date Received11/09/2018
Decision Date 12/06/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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