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FDA 510(k) Application Details - K150638
Device Classification Name
Ventilator, Continuous, Facility Use
More FDA Info for this Device
510(K) Number
K150638
Device Name
Ventilator, Continuous, Facility Use
Applicant
Respironics, Inc.
1001 Murry Ridge Lane
Murrysville, PA 15668 US
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Contact
Shaylee Masilunas
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
03/11/2015
Decision Date
09/18/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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