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FDA 510(k) Application Details - K122445
Device Classification Name
Gas-Machine, Anesthesia
More FDA Info for this Device
510(K) Number
K122445
Device Name
Gas-Machine, Anesthesia
Applicant
DATEX-OHMEDA
PO BOX 7550
3030 OHMEDA DR
MADISON, WI 53707 US
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Contact
JAMES RASKOB
Other 510(k) Applications for this Contact
Regulation Number
868.5160
More FDA Info for this Regulation Number
Classification Product Code
BSZ
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More FDA Info for this Product Code
Date Received
08/10/2012
Decision Date
10/12/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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