BlueStar Rx

Calculator, Drug Dose

WellDoc, Inc

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

Pre-market Notification Details

Device IDK203434
510k NumberK203434
Device Name:BlueStar Rx
ClassificationCalculator, Drug Dose
Applicant WellDoc, Inc 10221 Wincopin Circle, Suite 150 Columbia,  MD  21044
ContactSabyasachi Roy
CorrespondentSabyasachi Roy
WellDoc, Inc 10221 Wincopin Circle, Suite 150 Columbia,  MD  21044
Product CodeNDC  
CFR Regulation Number868.1890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-23
Decision Date2021-09-08

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