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FDA 510(k) Application Details - K071230
Device Classification Name
Ventilatory Effort Recorder
More FDA Info for this Device
510(K) Number
K071230
Device Name
Ventilatory Effort Recorder
Applicant
ADVANCED BRAIN MONITORING, INC.
2237 FARADAY AVENUE
SUITE 100
CARLSBAD, CA 92008 US
Other 510(k) Applications for this Company
Contact
DANIEL J LEVENDOWSKI
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
05/03/2007
Decision Date
10/03/2007
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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