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 Number | 862.1358
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/05/2023 |
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
|
|
|