Cleared Traditional

WellDoc BlueStar, WellDoc BlueStar Rx

K162532 · Welldoc, Inc. · General Hospital
Jan 2017
Decision
125d
Days
Class 2
Risk

About This 510(k) Submission

K162532 is an FDA 510(k) clearance for the WellDoc BlueStar, WellDoc BlueStar Rx, a Accessories, Pump, Infusion (Class II — Special Controls, product code MRZ), submitted by Welldoc, Inc. (Columbia, US). The FDA issued a Cleared decision on January 12, 2017, 125 days after receiving the submission on September 9, 2016. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K162532 FDA.gov
FDA Decision Cleared SESE
Date Received September 09, 2016
Decision Date January 12, 2017
Days to Decision 125 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