FDA 510(k) Application Details - K041819

Device Classification Name	Ventilator, Non-Continuous (Respirator)   More FDA Info for this Device
510(K) Number	K041819
Device Name	Ventilator, Non-Continuous (Respirator)
Applicant	MALLINCKRODT DEVELOPPEMENT FRANCE 4280 HACIENDA DR. PLEASANTON, CA 94588 US Other 510(k) Applications for this Company
Contact	JAMES BONDS 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	07/06/2004
Decision Date	07/22/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review