ACCU-CHEK 360 DIABETES MANAGEMENT SYSTEM


Device Classification Name

accessories, pump, infusion

510(k) Number K080227
Device Name ACCU-CHEK 360 DIABETES MANAGEMENT SYSTEM
Applicant
ROCHE DIAGNOSTICS CORP.
9115 hague rd.
indianapolis, 
IN 
46250

Applicant Contact scott thiel
Correspondent
ROCHE DIAGNOSTICS CORP.
9115 hague rd.
indianapolis, 
IN 
46250

Correspodent Contact scott thiel
Regulation Number 880.5725
Classification Product Code
MRZ  
Date Received 01/30/2008
Decision Date 05/15/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No