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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name vaporizer, anesthesia, non-heated
510(k) Number K002878
Device Name DATEX-OHMEDA D-TEC PLUS ANESTHESIA VAPORIZER
Applicant
DATEX-OHMEDA, INC.
OHMEDA DR.
P.O. BOX 7550
MADISON,  WI  53707 -7550
Applicant Contact DANIEL KOSEDNAR
Correspondent
DATEX-OHMEDA, INC.
OHMEDA DR.
P.O. BOX 7550
MADISON,  WI  53707 -7550
Correspondent Contact DANIEL KOSEDNAR
Regulation Number868.5880
Classification Product Code
CAD  
Date Received09/15/2000
Decision Date 09/21/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Special
Reviewed by Third Party No
Combination Product No
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