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FDA 510(k) Application Details - K113053
Device Classification Name
Ventilator, Continuous, Non-Life-Supporting
More FDA Info for this Device
510(K) Number
K113053
Device Name
Ventilator, Continuous, Non-Life-Supporting
Applicant
RESPIRONICS, INC.
1740 GOLDEN MILE HIGHWAY
MONROEVILLE, PA 15146 US
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Contact
ELAINE LARKIN
Other 510(k) Applications for this Contact
Regulation Number
868.5895
More FDA Info for this Regulation Number
Classification Product Code
MNS
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More FDA Info for this Product Code
Date Received
10/13/2011
Decision Date
02/01/2012
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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