MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP AND THE BD PARADIGM LINK GLUCOSE METER


Device Classification Name

pump, infusion, insulin

510(k) Number K030531
Device Name MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP AND THE BD PARADIGM LINK GLUCOSE METER
Applicant
MINIMED, INC.
18000 devonshire st.
northridge, 
CA 
91325

Applicant Contact gerda p resch
Correspondent
MINIMED, INC.
18000 devonshire st.
northridge, 
CA 
91325

Correspodent Contact gerda p resch
Regulation Number 880.5725
Classification Product Code
LZG  
Subsequent Product Code
NBW  
Date Received 02/19/2003
Decision Date 06/17/2003
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

Yes

Recalls CDRH Recalls