ABBOTT GEMSTAR I.V. INFUSION PUMP – 7 THERAPY CONFIGURATION, 6 THERAPY CONFIGURATION, 1 THERAPY CONFIGURATION


information about

Device Classification Name

pump, infusion

510(k) Number K000821
Device Name ABBOTT GEMSTAR I.V. INFUSION PUMP – 7 THERAPY CONFIGURATION, 6 THERAPY CONFIGURATION, 1 THERAPY CONFIGURATION
Original Applicant
ABBOTT LABORATORIES
dept. 389, ap30
200 abbott park rd.
abbott park, 
IL 
60064 -3537

Original Contact jill sackett
Regulation Number 880.5725
Classification Product Code
FRN  
Date Received 03/14/2000
Decision Date 03/24/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

Type Special
Reviewed by Third Party No

Combination Product

No