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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 K021955
Device Name TRUTRAK PLUS ENHANCEMENTS TO THE DATEX-OHMEDA 3800 SERIES & 3900 SERIES OXIMETERS & ACCESSORIES
Applicant
Datex-Ohmeda, Inc.
1315 W. Century Dr.
Louisville,  CO  80027
Applicant Contact MICHAEL A CHILBERT
Correspondent
Datex-Ohmeda, Inc.
1315 W. Century Dr.
Louisville,  CO  80027
Correspondent Contact MICHAEL A CHILBERT
Regulation Number870.2700
Classification Product Code
DQA  
Subsequent Product Code
DPZ  
Date Received06/14/2002
Decision Date 10/08/2002
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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