FDA 510(k) Application Details - K173205

Device Classification Name	Mixer, Breathing Gases, Anesthesia Inhalation   More FDA Info for this Device
510(K) Number	K173205
Device Name	Mixer, Breathing Gases, Anesthesia Inhalation
Applicant	O-Two Medical Technologies Inc. 45A Armthorpe Road Brampton L6T 5M4 CA Other 510(k) Applications for this Company
Contact	David Zhang Other 510(k) Applications for this Contact
Regulation Number	868.5330   More FDA Info for this Regulation Number
Classification Product Code	BZR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/02/2017
Decision Date	08/29/2018
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