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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Transmitters And Receivers, Physiological Signal, Radiofrequency
510(k) Number K052961
Device Name THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, AND MP90 INTELLIVUE PATIENT MONITORS, WITH 802.11 WIRELESS LAN
Applicant
Philips Medical Systems
3000 Minuteman Rd.
Andover,  MA  01810
Applicant Contact TAPAN D SHAH
Correspondent
Philips Medical Systems
3000 Minuteman Rd.
Andover,  MA  01810
Correspondent Contact TAPAN D SHAH
Regulation Number870.2910
Classification Product Code
DRG  
Date Received10/21/2005
Decision Date 11/18/2005
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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