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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gas-Machine, Anesthesia
510(k) Number K000706
Device Name DATEX-OHMEDA AESTIVA/5 WITH 7100 VENTILATOR
Applicant
Datex-Ohmeda, Inc.
Ohmeda Dr.
Madison,  WI  53707
Applicant Contact DANIEL KOSEDNAR
Correspondent
Datex-Ohmeda, Inc.
Ohmeda Dr.
Madison,  WI  53707
Correspondent Contact DANIEL KOSEDNAR
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received03/02/2000
Decision Date 05/11/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
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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