FDA 510(k) Application Details - K950853

Device Classification Name	Ventilator, Continuous, Facility Use   More FDA Info for this Device
510(K) Number	K950853
Device Name	Ventilator, Continuous, Facility Use
Applicant	DRAGER, INC. 4101 PLEASENT VALLEY ROAD, SUITE 100 CHANTILLY, VA 22021 US Other 510(k) Applications for this Company
Contact	HARALD KNEUER Other 510(k) Applications for this Contact
Regulation Number	868.5895   More FDA Info for this Regulation Number
Classification Product Code	CBK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/27/1995
Decision Date	11/05/1996
Decision	ST - Substantially Equivalent - Subject to Tracking Reg.
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status
Type	Traditional
Reviewed By Third Party	N
Expedited Review