FABIUS MRI


Device Classification Name

gas-machine, anesthesia

510(k) Number K072884
Device Name FABIUS MRI
Applicant
DRAEGER MEDICAL AG & CO. KG
3135 quarry road
telford, 
PA 
18969

Applicant Contact kathy anderson
Correspondent
DRAEGER MEDICAL AG & CO. KG
3135 quarry road
telford, 
PA 
18969

Correspodent Contact kathy anderson
Regulation Number 868.5160
Classification Product Code
BSZ  
Date Received 10/09/2007
Decision Date 07/30/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No