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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals
510(k) Number K232722
Device Name endo.digital Platform
Applicant
DreaMed Diabetes Ltd
14 Kaplan St, POB 3271
Petah Tikva,  IL 4952701
Applicant Contact Eran Atlas
Correspondent
DreaMed Diabetes Ltd
14 Kaplan St, POB 3271
Petah Tikva,  IL 4952701
Correspondent Contact Eran Atlas
Regulation Number862.1358
Classification Product Code
QCC  
Subsequent Product Code
NDC  
Date Received09/05/2023
Decision Date 10/03/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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