FDA 510(k) Application Details - K151361

Device Classification Name	Ventilatory Effort Recorder   More FDA Info for this Device
510(K) Number	K151361
Device Name	Ventilatory Effort Recorder
Applicant	NOX MEDICAL ehf KATRINARTUNI 2 REYKJAVIK 105 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	05/21/2015
Decision Date	11/06/2015
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