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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 K010463
Device Name DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSOIRES
Applicant
Datex-Ohmeda, Inc.
3 Highwood Dr.
Tewksburt,  MA  01876
Applicant Contact JOEL C KENT
Correspondent
Datex-Ohmeda, Inc.
3 Highwood Dr.
Tewksburt,  MA  01876
Correspondent Contact JOEL C KENT
Regulation Number870.2700
Classification Product Code
DQA  
Subsequent Product Code
DPZ  
Date Received02/16/2001
Decision Date 03/15/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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