FDA 510(k) Application Details - K962517

Device Classification Name	Ventilator, Continuous, Non-Life-Supporting   More FDA Info for this Device
510(K) Number	K962517
Device Name	Ventilator, Continuous, Non-Life-Supporting
Applicant	HEALTHDYNE TECHNOLOGIES, INC. 1850 PARKWAY PLACE MARIETTA, GA 30067 US Other 510(k) Applications for this Company
Contact	TIMOTHY Y COWART Other 510(k) Applications for this Contact
Regulation Number	868.5895   More FDA Info for this Regulation Number
Classification Product Code	MNS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/27/1996
Decision Date	02/20/1997
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