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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 K032979
Device Name PHILIPS SPO2 REUSABLE SENSORS, MODEL NOS. M1191T, M1192T, AND M1193T
Applicant
PHILIPS MEDICAL SYSTEMS, INC.
HEWLETT PACKARD STR. 2
BOBLINGEN,  DE D71034
Applicant Contact EGON PFEIL
Correspondent
PHILIPS MEDICAL SYSTEMS, INC.
HEWLETT PACKARD STR. 2
BOBLINGEN,  DE D71034
Correspondent Contact EGON PFEIL
Regulation Number870.2700
Classification Product Code
DQA  
Date Received09/24/2003
Decision Date 02/20/2004
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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