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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Network And Communication, Physiological Monitors
510(k) Number K020524
Device Name PATIENTNET MONITORING SYSTEM
Applicant
General Electric Medical Systems Information Techn
15222 Del Amo Ave.
Tustin,  CA  92780
Applicant Contact DIANA M THORSON
Correspondent
General Electric Medical Systems Information Techn
15222 Del Amo Ave.
Tustin,  CA  92780
Correspondent Contact DIANA M THORSON
Regulation Number870.2300
Classification Product Code
MSX  
Date Received02/19/2002
Decision Date 03/20/2002
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
Recalls CDRH Recalls
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