OPTION NIV, MODEL 8414115, UPGRADE KIT NIV, MODEL 8414072


Device Classification Name

ventilator, continuous, facility use

510(k) Number K023289
Device Name OPTION NIV, MODEL 8414115, UPGRADE KIT NIV, MODEL 8414072
Original Applicant
DRAGER MEDIZINTECHNIK GMBH
3136 quarry rd.
telford, 
PA 
18969

Original Contact james j brennan
Regulation Number 868.5895
Classification Product Code
CBK  
Date Received 10/02/2002
Decision Date 01/15/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No