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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name calculator, drug dose
510(k) Number K203434
Device Name BlueStar Rx
Applicant
WellDoc, Inc
10221 Wincopin Circle, Suite 150
Columbia,  MD  21044
Applicant Contact Sabyasachi Roy
Correspondent
WellDoc, Inc
10221 Wincopin Circle, Suite 150
Columbia,  MD  21044
Correspondent Contact Sabyasachi Roy
Regulation Number868.1890
Classification Product Code
NDC  
Date Received11/23/2020
Decision Date 09/08/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Clinical Chemistry
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT02813343
Reviewed by Third Party No
Combination Product No
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