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FDA 510(k) Application Details - K142679
Device Classification Name
Ventilator, Continuous, Facility Use
More FDA Info for this Device
510(K) Number
K142679
Device Name
Ventilator, Continuous, Facility Use
Applicant
Datex-Ohmeda, Inc.
3030 Ohmeda Drive, PO Box 7550
Madison, WI 53707-7550 US
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Contact
Trishia Dwyer
Other 510(k) Applications for this Contact
Regulation Number
868.5895
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Classification Product Code
CBK
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More FDA Info for this Product Code
Date Received
09/19/2014
Decision Date
06/12/2015
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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