FDA 510(k) Application Details - K124062

Device Classification Name	Ventilatory Effort Recorder   More FDA Info for this Device
510(K) Number	K124062
Device Name	Ventilatory Effort Recorder
Applicant	NOX MEDICAL VATNAGORDUM 18 REYKJAVIK 104 IS Other 510(k) Applications for this Company
Contact	KOLBRUN E OTTOSDOTTIR 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	12/31/2012
Decision Date	07/10/2013
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