FDA 510(k) Application Details - K161420

Device Classification Name	Ventilator, Emergency, Powered (Resuscitator)   More FDA Info for this Device
510(K) Number	K161420
Device Name	Ventilator, Emergency, Powered (Resuscitator)
Applicant	THORNHILL RESEARCH INC. 210 DUNDAS STREET WEST, SUITE 200 TORONTO M5G 2E8 CA Other 510(k) Applications for this Company
Contact	KIPTON LADE Other 510(k) Applications for this Contact
Regulation Number	868.5925   More FDA Info for this Regulation Number
Classification Product Code	BTL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/23/2016
Decision Date	06/06/2017
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