WellDoc BlueStar

Accessories, Pump, Infusion

WellDoc, Inc.

The following data is part of a premarket notification filed by Welldoc, Inc. with the FDA for Welldoc Bluestar.

Pre-market Notification Details

Device IDK190013
501k NumberK190013
Device Name:WellDoc BlueStar
ClassificationAccessories, Pump, Infusion
Applicant WellDoc, Inc. 10221 Wincopin Circle, Suite 150 Columbia,  MD  21044
ContactCaroline York
CorrespondentCaroline York
WellDoc, Inc. 10221 Wincopin Circle, Suite 150 Columbia,  MD  21044
Product CodeMRZ  
Subsequent Product CodeLNX
Subsequent Product CodeNDC
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral Hospital
501k Review PanelGeneral Hospital
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-01-03
Decision Date2019-11-04

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