WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM


Device Classification Name

accessories, pump, infusion

510(k) Number K112370
Device Name WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM
Applicant
WELLDOC, INC
1501 saint paul street
suite 118
baltimore, 
MD 
21202

Applicant Contact lauren bronich-hall
Correspondent
WELLDOC, INC
1501 saint paul street
suite 118
baltimore, 
MD 
21202

Correspodent Contact lauren bronich-hall
Regulation Number 880.5725
Classification Product Code
MRZ  
Subsequent Product Code
LNX  
Date Received 08/17/2011
Decision Date 10/14/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No