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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Pump, Infusion
510(k) Number K193654
Device Name BlueStar Rx
Applicant
Welldoc, Inc.
10221 Wincopin Cir., Suite 150
Columbia,  MD  21044
Applicant Contact Sabyasachi Roy
Correspondent
Welldoc, Inc.
10221 Wincopin Cir., Suite 150
Columbia,  MD  21044
Correspondent Contact Sabyasachi Roy
Regulation Number880.5725
Classification Product Code
MRZ  
Subsequent Product Code
NDC  
Date Received12/30/2019
Decision Date 04/07/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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