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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 K122445
Device Name AESPIRE 7900, AESPIRE VIEW
Applicant
DATEX-OHMEDA
PO BOX 7550
3030 OHMEDA DR
MADISON,  WI  53707
Applicant Contact JAMES RASKOB
Correspondent
DATEX-OHMEDA
PO BOX 7550
3030 OHMEDA DR
MADISON,  WI  53707
Correspondent Contact JAMES RASKOB
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received08/10/2012
Decision Date 10/12/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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