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FDA 510(k) Application Details - K112514
Device Classification Name
Ventilatory Effort Recorder
More FDA Info for this Device
510(K) Number
K112514
Device Name
Ventilatory Effort Recorder
Applicant
ADVANCED BRAIN MONITORING, INC.
2511 FOX RIVER CIRCLE
WAUKESHA, WI 53189 US
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Contact
ADRIENNE LENZ
Other 510(k) Applications for this Contact
Regulation Number
868.2375
More FDA Info for this Regulation Number
Classification Product Code
MNR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/30/2011
Decision Date
01/09/2012
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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