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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 K042306
Device Name PHILIPS SP02 DISPOSABLE SENSOR, MODEL M1131A
Applicant
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH
HEWLETT-PACKARD STR.2
BOEBLINGEN,  DE D 71034
Applicant Contact EGON PFEIL
Correspondent
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH
HEWLETT-PACKARD STR.2
BOEBLINGEN,  DE D 71034
Correspondent Contact EGON PFEIL
Regulation Number870.2700
Classification Product Code
DQA  
Date Received08/25/2004
Decision Date 10/15/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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