FDA 510(k) Application Details - K170663

Device Classification Name	Ventilator, Emergency, Manual (Resuscitator)   More FDA Info for this Device
510(K) Number	K170663
Device Name	Ventilator, Emergency, Manual (Resuscitator)
Applicant	Foremount Enterprise Co., Ltd. No. 17, Alley 15, Lane 5, Shenan St., Shengang Dist., Taichung City 42944 TW Other 510(k) Applications for this Company
Contact	John Yang Other 510(k) Applications for this Contact
Regulation Number	868.5915   More FDA Info for this Regulation Number
Classification Product Code	BTM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/06/2017
Decision Date	05/11/2018
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