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510(k) K201476

Device
DreaMed Advisor Pro
Applicant
DreaMed Diabetes Ltd
510(k) number
K201476
Product code
QCC  
Decision
Substantially Equivalent (SESE)
Decision date
2020-08-28
Date received
2020-06-03
Regulation
862.1358
Classification name
Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Inbal Beinglass Peled
Address
5 Mota Gur St. Petah Tikva IL 4952701 4952701

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QCC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K232722endo.digital PlatformDreaMed Diabetes, Ltd.2023-10-03
K210561Advisor Pro PlatformDreaMed Diabetes, Ltd.2021-09-28
K191370DreaMed Advisor ProDreaMed Diabetes, Ltd.2019-07-18
DEN170043DreaMed Advisor ProDreaMed Diabetes, Ltd.2018-06-12

Legacy Summary#

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FDA Review#

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