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FDA 510(k) Application Details - K052489
Device Classification Name
Conditioner, Signal, Physiological
More FDA Info for this Device
510(K) Number
K052489
Device Name
Conditioner, Signal, Physiological
Applicant
RESPIRONICS, INC.
1001 MURRY RIDGE LN.
MURRYSVILLE, PA 15668 US
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Contact
ZITA A YURKO
Other 510(k) Applications for this Contact
Regulation Number
882.1845
More FDA Info for this Regulation Number
Classification Product Code
GWK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/12/2005
Decision Date
09/27/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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