AUTOMED 3300 AND 3400 INFUSION PUMP SYSTEM


Device Classification Name

pump, infusion

510(k) Number K023491
Device Name AUTOMED 3300 AND 3400 INFUSION PUMP SYSTEM
Original Applicant
HELP TECHNOLOGIES
24312 armada dr.
dana point, 
CA 
92629

Original Contact robert j bard
Regulation Number 880.5725
Classification Product Code
FRN  
Subsequent Product Code
MEA  
Date Received 10/17/2002
Decision Date 12/13/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No