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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 K252104
Device Name T1D1
Applicant
Comerge AG
Bubenbergestrasse 1
Zurich,  CH 8045
Applicant Contact Andreas Pedroni
Correspondent
Comerge AG
Bubenbergestrasse 1
Zurich,  CH 8045
Correspondent Contact Andreas Pedroni
Regulation Number868.1890
Classification Product Code
NDC  
Date Received07/03/2025
Decision Date 08/20/2025
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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