Cleared Special

WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM

K112370 · Welldoc, Inc. · General Hospital
Oct 2011
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K112370 is an FDA 510(k) clearance for the WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM, a Accessories, Pump, Infusion (Class II — Special Controls, product code MRZ), submitted by Welldoc, Inc. (Baltimore, US). The FDA issued a Cleared decision on October 14, 2011, 58 days after receiving the submission on August 17, 2011. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K112370 FDA.gov
FDA Decision Cleared SESE
Date Received August 17, 2011
Decision Date October 14, 2011
Days to Decision 58 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Statement

Device Classification

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