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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 K001688
Device Name DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER
Applicant
Datex-Ohmeda, Inc.
1315 W. Century Dr.
Louisville,  CO  80027
Applicant Contact DALE THANIG
Correspondent
Datex-Ohmeda, Inc.
1315 W. Century Dr.
Louisville,  CO  80027
Correspondent Contact DALE THANIG
Regulation Number870.2700
Classification Product Code
DQA  
Date Received06/02/2000
Decision Date 06/30/2000
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
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