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FDA 510(k) Application Details - K082966
Device Classification Name
Ventilator, Continuous, Facility Use
More FDA Info for this Device
510(K) Number
K082966
Device Name
Ventilator, Continuous, Facility Use
Applicant
COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT INC.
6135 Gunbarrel Ave
BOULDER, CO 80301 US
Other 510(k) Applications for this Company
Contact
TINA O'BRIEN
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
10/06/2008
Decision Date
10/31/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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