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FDA 510(k) Application Details - K981072
Device Classification Name
Ventilator, Continuous, Facility Use
More FDA Info for this Device
510(K) Number
K981072
Device Name
Ventilator, Continuous, Facility Use
Applicant
RESPIRONICS, INC.
1501 ARDMORE BLVD.
PITTSBURGH, PA 15221-4401 US
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Contact
PAUL WOODRING
Other 510(k) Applications for this Contact
Regulation Number
868.5895
More FDA Info for this Regulation Number
Classification Product Code
CBK
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More FDA Info for this Product Code
Date Received
03/24/1998
Decision Date
11/12/1998
Decision
ST - Substantially Equivalent - Subject to Tracking Reg.
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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