FDA 510(k) Application Details - K173770

Device Classification Name	Valve, Non-Rebreathing   More FDA Info for this Device
510(K) Number	K173770
Device Name	Valve, Non-Rebreathing
Applicant	Fisher & Paykel Healthcare Limited 15 Maurice Paykel Place, East Tamaki Auckland 2013 NZ Other 510(k) Applications for this Company
Contact	Adele Bindon Other 510(k) Applications for this Contact
Regulation Number	868.5870   More FDA Info for this Regulation Number
Classification Product Code	CBP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/11/2017
Decision Date	04/05/2019
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