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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 K102974
Device Name INTELLISPHERE EVENT MANAGMENT SYSTEM REL. 10.00
Applicant
Philips Medical Systems
6400 N. Congress Ave.
Suite 1050
Boca Raton,  FL  33487
Applicant Contact GARY BECKER
Correspondent
Philips Medical Systems
6400 N. Congress Ave.
Suite 1050
Boca Raton,  FL  33487
Correspondent Contact GARY BECKER
Regulation Number870.2300
Classification Product Code
MSX  
Date Received10/06/2010
Decision Date 01/04/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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