510(k) K141273

WELLDOC DIABETESMANAGER SYSTEM AND DIABETESMANAGER- RX SYSTE by Welldoc, Inc. — Product Code MRZ

K141273 is an FDA 510(k) premarket notification submitted by Welldoc, Inc. for the device "WELLDOC DIABETESMANAGER SYSTEM AND DIABETESMANAGER- RX SYSTE". The FDA issued a decision of Substantially Equivalent on July 8, 2014. The device falls under product code MRZ (Accessories, Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Welldoc, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 2014
Date Received
May 16, 2014
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Pump, Infusion
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type