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FDA 510(k) Application Details - K083526
Device Classification Name
Ventilator, Continuous, Facility Use
More FDA Info for this Device
510(K) Number
K083526
Device Name
Ventilator, Continuous, Facility Use
Applicant
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP
1740 GOLDEN MILE HWY
MONROEVILLE, PA 15146 US
Other 510(k) Applications for this Company
Contact
ZITA A YURKO
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
11/28/2008
Decision Date
03/13/2009
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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