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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 K091176
Device Name PHILIPS TELEMEDICINE SERVER/SYSTEM, MODEL 861441
Applicant
Philips Medical Systems
3000 Minuteman Rd.
M/S 0220
Andover,  MA  01810
Applicant Contact PAUL SCHRADER
Correspondent
Philips Medical Systems
3000 Minuteman Rd.
M/S 0220
Andover,  MA  01810
Correspondent Contact PAUL SCHRADER
Regulation Number870.2300
Classification Product Code
MSX  
Date Received04/22/2009
Decision Date 11/13/2009
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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