Cleared Traditional

WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System

K162225 · Welldoc, Inc. · General Hospital
Nov 2016
Decision
106d
Days
Class 2
Risk

About This 510(k) Submission

K162225 is an FDA 510(k) clearance for the WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System, a Accessories, Pump, Infusion (Class II — Special Controls, product code MRZ), submitted by Welldoc, Inc. (Columbia, US). The FDA issued a Cleared decision on November 22, 2016, 106 days after receiving the submission on August 8, 2016. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K162225 FDA.gov
FDA Decision Cleared SESE
Date Received August 08, 2016
Decision Date November 22, 2016
Days to Decision 106 days
Submission Type Traditional
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