FDA 510(k) Application Details - K973975

Device Classification Name	Ventilator, Emergency, Powered (Resuscitator)   More FDA Info for this Device
510(K) Number	K973975
Device Name	Ventilator, Emergency, Powered (Resuscitator)
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	868.5925   More FDA Info for this Regulation Number
Classification Product Code	BTL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/20/1997
Decision Date	06/12/1998
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