EZ MANAGER MAX DIABETES MANAGEMENT SOFTWARE


Device Classification Name

accessories, pump, infusion

510(k) Number K080587
Device Name EZ MANAGER MAX DIABETES MANAGEMENT SOFTWARE
Applicant
ANIMAS CORP.
200 lawrence dr.
west chester, 
PA 
19380

Applicant Contact jennifer bosley
Correspondent
ANIMAS CORP.
200 lawrence dr.
west chester, 
PA 
19380

Correspodent Contact jennifer bosley
Regulation Number 880.5725
Classification Product Code
MRZ  
Date Received 03/03/2008
Decision Date 05/15/2008
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

Recalls CDRH Recalls