FDA 510(k) Application Details - K003684

Device Classification Name	Device, Positive Pressure Breathing, Intermittent   More FDA Info for this Device
510(K) Number	K003684
Device Name	Device, Positive Pressure Breathing, Intermittent
Applicant	VORTRAN MEDICAL TECHNOLOGY 1, INC. 3941 J ST., SUITE 354 SACRAMENTO, CA 95819 US Other 510(k) Applications for this Company
Contact	GORDON A WONG Other 510(k) Applications for this Contact
Regulation Number	868.5905   More FDA Info for this Regulation Number
Classification Product Code	NHJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/29/2000
Decision Date	02/23/2001
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