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FDA 510(k) Application Details - K112393
Device Classification Name
Ventilator, Non-Continuous (Respirator)
More FDA Info for this Device
510(K) Number
K112393
Device Name
Ventilator, Non-Continuous (Respirator)
Applicant
RESMED LTD.
9001 SPECTRUM CENTER BLVD.
SAN DIEGO, CA 92123 US
Other 510(k) Applications for this Company
Contact
DAVID D'CRUZ
Other 510(k) Applications for this Contact
Regulation Number
868.5905
More FDA Info for this Regulation Number
Classification Product Code
BZD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/19/2011
Decision Date
11/16/2011
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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