I-FLOW ELASTOMERIC PUMP WITH BOLUS


Device Classification Name

pump, infusion, elastomeric

510(k) Number K023318
Device Name I-FLOW ELASTOMERIC PUMP WITH BOLUS
Original Applicant
I-FLOW CORP.
20202 windrow dr.
lake forest, 
CA 
92630

Original Contact shane noehre
Regulation Number 880.5725
Classification Product Code
MEB  
Date Received 10/04/2002
Decision Date 10/18/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls