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FDA 510(k) Application Details - K102985
Device Classification Name
Ventilator, Continuous, Minimal Ventilatory Support,Facility Use
More FDA Info for this Device
510(K) Number
K102985
Device Name
Ventilator, Continuous, Minimal Ventilatory Support,Facility Use
Applicant
Respironics Inc.
1001 Murry Ridge Lane
Murrysville, PA 15668 US
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Contact
TAMATHA LEY
Other 510(k) Applications for this Contact
Regulation Number
868.5895
More FDA Info for this Regulation Number
Classification Product Code
MNT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/07/2010
Decision Date
04/05/2011
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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