FDA 510(k) Application Details - K120920

Device Classification Name	Ventilator, Non-Continuous (Respirator)   More FDA Info for this Device
510(K) Number	K120920
Device Name	Ventilator, Non-Continuous (Respirator)
Applicant	HSINER COMPANY 29201 VIA NORTE TEMECULA, CA 92591 US Other 510(k) Applications for this Company
Contact	TOM SHANKS Other 510(k) Applications for this Contact
Regulation Number	868.5905   More FDA Info for this Regulation Number
Classification Product Code	BZD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/27/2012
Decision Date	07/16/2012
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