DATEX-OHMEDA 7900 VENTILATOR ENHANCEMENTS


Device Classification Name

ventilator, continuous, facility use

510(k) Number K023366
Device Name DATEX-OHMEDA 7900 VENTILATOR ENHANCEMENTS
Original Applicant
DATEX-OHMEDA, INC.
p.o. box 7550
madison, 
WI 
53707

Original Contact michael a chilbert
Regulation Number 868.5895
Classification Product Code
CBK  
Date Received 10/08/2002
Decision Date 10/07/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls