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FDA 510(k)

endo.digital Platform

K-Number: K232722 · 2023-10-03

ApplicantDreaMed Diabetes, Ltd.
Decision Date2023-10-03
Product CodeQCC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

endo.digital Platform is a medical device manufactured by DreaMed Diabetes, Ltd.. It received FDA 510(k) clearance on 2023-10-03 under approval number K232722. The device is classified under product code QCC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the endo.digital Platform?

endo.digital Platform is a medical device that received FDA 510(k) clearance on 2023-10-03. It is manufactured by DreaMed Diabetes, Ltd.. The 510(k) number is K232722.

When was endo.digital Platform approved by the FDA?

endo.digital Platform received FDA 510(k) clearance on 2023-10-03, under approval number K232722.

What company makes endo.digital Platform?

endo.digital Platform is manufactured by DreaMed Diabetes, Ltd..

What is the FDA product code for endo.digital Platform?

The FDA product code for endo.digital Platform is QCC.

Related Clinical Trials

NCT07595289 DP-DCT 1.0：A Comparative Clinical Study on the Effect of Dapagliflozin Combined With CGM Versus SMBG on Glycemic Control in Patients With Type 2 Diabetes Mellitus Based on the DP-DCT Platform NOT_YET_RECRUITING NCT07593872 XR-Assisted PET/CT Navigation for Cervical Lymph Node Dissection in Lung Cancer NOT_YET_RECRUITING NCT07232667 Digital Technology for Active and Healthy Ageing in Taiwan RECRUITING NCT06669780 e-CBT DTx for Post Traumatic Headaches in Adults With History of TBI COMPLETED NCT07578142 AcceXible Speech-Based Screening for Depression and Anxiety in University Students (UAQ, Mexico) NOT_YET_RECRUITING NCT07578155 Validation of Accexible Screening and Self-Administered Activities for Emotional Well-Being in a University Hospital (UaDEC) COMPLETED

Related PubMed Literature

PMID: 42204020 A Minimal UDI-DICOM Mapping Profile and Validation Artifact for Medical-Device Imaging Workflows. Journal of imaging informatics in medicine (2026)

Other Devices by DreaMed Diabetes, Ltd.

DEN170043DreaMed Advisor Pro K191370DreaMed Advisor Pro K201476DreaMed Advisor Pro K210561Advisor Pro Platform

Related Devices (Code: QCC)

DEN170043DreaMed Advisor ProDreaMed Diabetes, Ltd. K191370DreaMed Advisor ProDreaMed Diabetes, Ltd. K201476DreaMed Advisor ProDreaMed Diabetes, Ltd. K210561Advisor Pro PlatformDreaMed Diabetes, Ltd.

Official Source

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