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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 K170199
Device Name Unity Network ID
Applicant
GE Healthcare
8200 W. Tower Ave.
Milwaukee,  WI  53223
Applicant Contact Robert Casarsa
Correspondent
GE Healthcare
8200 W. Tower Ave.
Milwaukee,  WI  53223
Correspondent Contact Robert Casarsa
Regulation Number870.2300
Classification Product Code
MWI  
Date Received01/23/2017
Decision Date 05/12/2017
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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