Cleared Special

WELLDOC DIABETESMANAGER SYSTEM AND DIABETESMANAGER- RX SYSTE

K141273 · Welldoc, Inc. · General Hospital
Jul 2014
Decision
53d
Days
Class 2
Risk

About This 510(k) Submission

K141273 is an FDA 510(k) clearance for the WELLDOC DIABETESMANAGER SYSTEM AND DIABETESMANAGER- RX SYSTE, a Accessories, Pump, Infusion (Class II — Special Controls, product code MRZ), submitted by Welldoc, Inc. (Baltimore, US). The FDA issued a Cleared decision on July 8, 2014, 53 days after receiving the submission on May 16, 2014. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K141273 FDA.gov
FDA Decision Cleared SESE
Date Received May 16, 2014
Decision Date July 08, 2014
Days to Decision 53 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code MRZ — Accessories, Pump, Infusion
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5725