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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter
510(k) Number K062268
Device Name MASIMO SET SPO2 MODULE FOR PHILIPS AND M3001A MULTI-MEASUREMENT SERVER OPTION A03
Applicant
PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
3000 MINUTEMAN ROAD
ANDOVER,  MA  01810 -1099
Applicant Contact DAVID OSBORN
Correspondent
PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
3000 MINUTEMAN ROAD
ANDOVER,  MA  01810 -1099
Correspondent Contact DAVID OSBORN
Regulation Number870.2700
Classification Product Code
DQA  
Date Received08/07/2006
Decision Date 10/18/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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