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FDA 510(k) Application Details - K103578
Device Classification Name
Spirometer, Monitoring (W/Wo Alarm)
More FDA Info for this Device
510(K) Number
K103578
Device Name
Spirometer, Monitoring (W/Wo Alarm)
Applicant
RESPIRONICS NOVAMETRIX, LLC
5 TECHNOLOGY DRIVE
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
12/06/2010
Decision Date
06/02/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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