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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 K032537
Device Name DRAEGER MICRO2+ AND MASIMO MINISAT
Applicant
Draeger Medical Systems, Inc.
16 ELECTRONICS AVE.
DANVERS,  MA  01923
Applicant Contact PENELOPE H GRECO
Correspondent
Draeger Medical Systems, Inc.
16 ELECTRONICS AVE.
DANVERS,  MA  01923
Correspondent Contact PENELOPE H GRECO
Regulation Number870.2700
Classification Product Code
DQA  
Subsequent Product Code
DPZ  
Date Received08/18/2003
Decision Date 11/25/2003
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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