FDA 510(k) Application Details - K052597

Device Classification Name	Ventilator, Non-Continuous (Respirator)   More FDA Info for this Device
510(K) Number	K052597
Device Name	Ventilator, Non-Continuous (Respirator)
Applicant	HOFFMAN LABORATORIES, LLC 9305 ETON AVENUE CHATSWORTH, CA 91311 US Other 510(k) Applications for this Company
Contact	KEITH BOSECKER 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	09/21/2005
Decision Date	12/16/2005
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