FOURTH GAS MODULE WITH CO2 FOR PRIMUS US APOLLO


Device Classification Name

gas-machine, anesthesia

510(k) Number K081447
Device Name FOURTH GAS MODULE WITH CO2 FOR PRIMUS US APOLLO
Applicant
DRAEGER MEDICAL AG & CO. KG
53/55 moislinger allee
luebeck, 

DE

23542

Applicant Contact karin luebbers
Correspondent
DRAEGER MEDICAL AG & CO. KG
53/55 moislinger allee
luebeck, 

DE

23542

Correspodent Contact karin luebbers
Regulation Number 868.5160
Classification Product Code
BSZ  
Date Received 05/22/2008
Decision Date 10/08/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No