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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 K092864
Device Name AESPIRE 7900, AESPIRE VIEW
Applicant
DATEX-OHMEDA INC., A DIVISION OF INSTRUMENTARIUM C
PO BOX 7550
3030 OHMEDA DRIVE
MADISON,  WI  53707 -7550
Applicant Contact ADRIENNE LENZ
Correspondent
DATEX-OHMEDA INC., A DIVISION OF INSTRUMENTARIUM C
PO BOX 7550
3030 OHMEDA DRIVE
MADISON,  WI  53707 -7550
Correspondent Contact ADRIENNE LENZ
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received09/17/2009
Decision Date 01/12/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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