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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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