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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 WEST CENTURY DR.
LOUISVILLE,  CO  80027
Applicant Contact SCOTT LIGHT
Correspondent
DATEX-OHMEDA, INC.
1315 WEST 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
Recalls CDRH Recalls
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