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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 K082888
Device Name INFINITY NELLCOR OXIMAX SMARTPOD, MODEL MS23997
Applicant
Draeger Medical Systems, Inc.
6 Tech Dr.
Andover,  MA  01810
Applicant Contact PRADEEP GUPTA
Correspondent
Draeger Medical Systems, Inc.
6 Tech Dr.
Andover,  MA  01810
Correspondent Contact PRADEEP GUPTA
Regulation Number870.2700
Classification Product Code
DQA  
Date Received09/30/2008
Decision Date 11/26/2008
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
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