Cleared Traditional

WellDoc BlueStar

K190013 · Welldoc, Inc. · General Hospital
Nov 2019
Decision
305d
Days
Class 2
Risk

About This 510(k) Submission

K190013 is an FDA 510(k) clearance for the WellDoc BlueStar, 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 4, 2019, 305 days after receiving the submission on January 3, 2019. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K190013 FDA.gov
FDA Decision Cleared SESE
Date Received January 03, 2019
Decision Date November 04, 2019
Days to Decision 305 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

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