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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 K230813
Device Name BlueStar and BlueStar Rx
Applicant
Welldoc, Inc.
10221 Wincopin Cir., Suite 150
Columbia,  MD  21044
Applicant Contact David Boser
Correspondent
Welldoc, Inc.
10221 Wincopin Cir., Suite 150
Columbia,  MD  21044
Correspondent Contact David Boser
Regulation Number868.1890
Classification Product Code
NDC  
Date Received03/24/2023
Decision Date 07/28/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
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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