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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 K041674
Device Name THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3814A SPO2 UNIT
Applicant
PHILIPS MEDICAL SYSTEMS
3000 MINUTEMAN RD.
ANDOVER,  MA  01810 -1099
Applicant Contact J.P. OUELLETTE
Correspondent
PHILIPS MEDICAL SYSTEMS
3000 MINUTEMAN RD.
ANDOVER,  MA  01810 -1099
Correspondent Contact J.P. OUELLETTE
Regulation Number870.2700
Classification Product Code
DQA  
Date Received06/21/2004
Decision Date 07/19/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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