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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 K033715
Device Name PICOSAT II SP02 PULSE OXIMETRY MODULE AND M3001A MULTI-MEASUREMENT SERVER
Applicant
Philips Medical Systems, Inc.
3000 Minuteman Rd.
Andover,  MA  01810
Applicant Contact DAVID OSBORN
Correspondent
Philips Medical Systems, Inc.
3000 Minuteman Rd.
Andover,  MA  01810
Correspondent Contact DAVID OSBORN
Regulation Number870.2700
Classification Product Code
DQA  
Subsequent Product Code
DPZ  
Date Received11/26/2003
Decision Date 02/13/2004
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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