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FDA 510(k) Application Details - K092217
Device Classification Name
Spirometer, Monitoring (W/Wo Alarm)
More FDA Info for this Device
510(K) Number
K092217
Device Name
Spirometer, Monitoring (W/Wo Alarm)
Applicant
RESPIRONICS NOVAMETRIX, INC.
5 TECHNOLOGY DR.
WALLINGFORD, CT 06492 US
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Contact
KEVIN MADER
Other 510(k) Applications for this Contact
Regulation Number
868.1850
More FDA Info for this Regulation Number
Classification Product Code
BZK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/22/2009
Decision Date
08/21/2009
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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