BlueStar Rx

Accessories, Pump, Infusion

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 IDK193654
510k NumberK193654
Device Name:BlueStar Rx
ClassificationAccessories, Pump, Infusion
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 CodeMRZ  
Subsequent Product CodeLNX
Subsequent Product CodeNDC
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-30
Decision Date2020-04-07

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B553HLTHOPTIMIZERX120 K193654 000
B553HLTHOPTIMIZER190 K193654 000
B553HLTHOPTIMIZER180 K193654 000
B553HLTHOPTIMIZER150 K193654 000
B553HLTHOPTIMIZERX150 K193654 000
B553HLTHOPTIMIZER170 K193654 000
B553HLTHOPTIMIZERRX170 K193654 000
B553HLTHOPTIMIZER160 K193654 000
B553HLTHOPTIMIZERRX160 K193654 000
B553HLTHOPTIMIZER140 K193654 000
B553HLTHOPTIMIZERX140 K193654 000
B553HLTHOPTIMIZER130 K193654 000
B553HLTHOPTIMIZERX130 K193654 000
B553202093OTC0 K193654 000

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