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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 K090360
Device Name PHILIPS M3001A MULTI MEASUREMENT SERVER
Applicant
PHILIPS MEDIZIN SYSTEME BOBLINGEN GMBH
HEWLETT-PACKARD-STR. 2
BOBLINGEN,  DE D-71034
Applicant Contact JENS-PETER SEHER
Correspondent
PHILIPS MEDIZIN SYSTEME BOBLINGEN GMBH
HEWLETT-PACKARD-STR. 2
BOBLINGEN,  DE D-71034
Correspondent Contact JENS-PETER SEHER
Regulation Number870.2700
Classification Product Code
DQA  
Subsequent Product Code
DPZ  
Date Received02/12/2009
Decision Date 05/04/2009
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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