FABIUS GS ANESTHESIA SYSTEM, MODEL FABIUS GS


Device Classification Name

gas-machine, anesthesia

510(k) Number K011404
Device Name FABIUS GS ANESTHESIA SYSTEM, MODEL FABIUS GS
Original Applicant
DRAEGER MEDICAL, INC.
3135 quarry rd.
telford, 
PA 
18969

Original Contact michail a kelhart
Regulation Number 868.5160
Classification Product Code
BSZ  
Date Received 05/08/2001
Decision Date 02/22/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

Type Traditional
Reviewed by Third Party No

Combination Product

No