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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 K071982
Device Name MODIFICATION TO: UNITY NETWORK ID
Applicant
Ge Medical Systems Information Technologies
8200 W. Tower Ave.
Milwaukee,  WI  53223
Applicant Contact LISA M BAUMHARDT
Correspondent
Ge Medical Systems Information Technologies
8200 W. Tower Ave.
Milwaukee,  WI  53223
Correspondent Contact LISA M BAUMHARDT
Regulation Number870.2300
Classification Product Code
MWI  
Date Received07/19/2007
Decision Date 09/21/2007
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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