FDA 510(k) Application Details - K042294

Device Classification Name	Ventilator, Non-Continuous (Respirator)   More FDA Info for this Device
510(K) Number	K042294
Device Name	Ventilator, Non-Continuous (Respirator)
Applicant	SUITER ENTERPRISES, INC. 21230 SE 363RD ST. AUBURN, WA 98092 US Other 510(k) Applications for this Company
Contact	TIMOTHY J.S. SUITER 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	08/24/2004
Decision Date	09/10/2004
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