Cleared Special

WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM

K120314 · Welldoc, Inc. · General Hospital
Feb 2012
Decision
23d
Days
Class 2
Risk

About This 510(k) Submission

K120314 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 February 24, 2012, 23 days after receiving the submission on February 1, 2012. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K120314 FDA.gov
FDA Decision Cleared SESE
Date Received February 01, 2012
Decision Date February 24, 2012
Days to Decision 23 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