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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 K011670
Device Name DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSORIES (WITH TRUTRAK+MOTION CORRECTION PERFORMANCE
Applicant
DATEX-OHMEDA
THREE HIGHWOOD DR.
TEWKSBURY,  MA  01876
Applicant Contact JOEL C KENT
Correspondent
DATEX-OHMEDA
THREE HIGHWOOD DR.
TEWKSBURY,  MA  01876
Correspondent Contact JOEL C KENT
Regulation Number870.2700
Classification Product Code
DQA  
Date Received05/30/2001
Decision Date 06/26/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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