FDA 510(k) Application Details - K001845

Device Classification Name	Ventilator, Non-Continuous (Respirator)   More FDA Info for this Device
510(K) Number	K001845
Device Name	Ventilator, Non-Continuous (Respirator)
Applicant	MALLINCKRODT DEVELOPPEMENT FRANCE 10 ALLEE PELLETIER DOISY VILLERS-LES-NANCY 54601 FR Other 510(k) Applications for this Company
Contact	MOUSTAFA ANKI 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	06/19/2000
Decision Date	07/05/2000
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