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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter, Ear
510(k) Number K040831
Device Name DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500
Applicant
Datex-Ohmeda, Inc.
1315 W. Century Dr.
Louisville,  CO  80027
Applicant Contact SCOTT LIGHT
Correspondent
Datex-Ohmeda, Inc.
1315 W. Century Dr.
Louisville,  CO  80027
Correspondent Contact SCOTT LIGHT
Regulation Number870.2710
Classification Product Code
DPZ  
Date Received03/31/2004
Decision Date 09/02/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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