SWEETSPOT DIABETES DATA MANAGEMENT SERVICE


Device Classification Name

system, test, blood glucose, over the counter

510(k) Number K111509
Device Name SWEETSPOT DIABETES DATA MANAGEMENT SERVICE
Applicant
SWEETSPOT DIABETES CARE, INC.
2538 ne 48th ave
portland, 
OR 
97213 -1924

Applicant Contact chris logan
Correspondent
SWEETSPOT DIABETES CARE, INC.
2538 ne 48th ave
portland, 
OR 
97213 -1924

Correspodent Contact chris logan
Regulation Number 862.1345
Classification Product Code
NBW  
Subsequent Product Code
JQP  
Date Received 06/01/2011
Decision Date 11/09/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No