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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name analyzer, gas, carbon-dioxide, gaseous-phase
510(k) Number K993656
Device Name DATEX-OHMEDA TONOMETRY MODULE M-TONO
Applicant
DATEX-OHMEDA, INC.
3 HIGHWOOD DR.
TEWKSBURY,  MA  01876
Applicant Contact JOEL C KENT
Correspondent
DATEX-OHMEDA, INC.
3 HIGHWOOD DR.
TEWKSBURY,  MA  01876
Correspondent Contact JOEL C KENT
Regulation Number868.1400
Classification Product Code
CCK  
Date Received10/29/1999
Decision Date 03/15/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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