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FDA 510(k) Application Details - K992530
Device Classification Name
Ventilator, Continuous, Non-Life-Supporting
More FDA Info for this Device
510(K) Number
K992530
Device Name
Ventilator, Continuous, Non-Life-Supporting
Applicant
RESPIRONICS, INC.
1001 MURRY RIDGE LN.
MURRYSVILLE, PA 15668 US
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Contact
DAVID J VANELLA
Other 510(k) Applications for this Contact
Regulation Number
868.5895
More FDA Info for this Regulation Number
Classification Product Code
MNS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/28/1999
Decision Date
03/20/2000
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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