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FDA 510(k) Application Details - K172799
Device Classification Name
Ventilatory Effort Recorder
More FDA Info for this Device
510(K) Number
K172799
Device Name
Ventilatory Effort Recorder
Applicant
Advanced Brain Monitoring
2237 Faraday Ave, Suite 100
Carlsbad, CA 92008 US
Other 510(k) Applications for this Company
Contact
Daniela Soll
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
09/18/2017
Decision Date
03/09/2018
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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