FDA 510(k) Application Details - K032596

Device Classification Name	Ventilator, Emergency, Manual (Resuscitator)   More FDA Info for this Device
510(K) Number	K032596
Device Name	Ventilator, Emergency, Manual (Resuscitator)
Applicant	STURDY INDUSTRIAL CO., LTD 6833 SAINT LAWRENCE STREET PLANO, TX 75024 US Other 510(k) Applications for this Company
Contact	ERIC LUO 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	08/22/2003
Decision Date	08/05/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review