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FDA 510(k) Application Details - K120931
Device Classification Name
Ventilator, Continuous, Facility Use
More FDA Info for this Device
510(K) Number
K120931
Device Name
Ventilator, Continuous, Facility Use
Applicant
ORICARE, INC.
1900 AM DRIVE
QUAKERTOWN, PA 18951 US
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Contact
DAVID JAMISON
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
03/27/2012
Decision Date
06/06/2013
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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