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FDA 510(k) Application Details - K093886
Device Classification Name
Ventilator, Continuous, Facility Use
More FDA Info for this Device
510(K) Number
K093886
Device Name
Ventilator, Continuous, Facility Use
Applicant
DATEX-OHMEDA INC., A DIVISION OF INSTRUMENTARIUM C
3030 OHMEDA DRIVE
MADISON, WI 53718-6794 US
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Contact
JIM RASKOB
Other 510(k) Applications for this Contact
Regulation Number
868.5895
More FDA Info for this Regulation Number
Classification Product Code
CBK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/18/2009
Decision Date
05/03/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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