MODIFICATION TO KION ANESTHESIA SYSTEM


codes

Device Classification Name

gas-machine, anesthesia

510(k) Number K001315
Device Name MODIFICATION TO KION ANESTHESIA SYSTEM
Original Applicant
SIEMENS ELEMA AB
electromedical systems group
16 electronics avenue
danvers, 
MA 
01923

Original Contact dave simard
Regulation Number 868.5160
Classification Product Code
BSZ  
Subsequent Product Code
MHX  
Date Received 04/26/2000
Decision Date 05/26/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

Type Special
Reviewed by Third Party No

Combination Product

No