Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is DreaMed Diabetes, Ltd.. It received FDA 510(k) clearance on 2023-10-03 under 510(k) 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. The listed applicant is DreaMed Diabetes, Ltd.. The 510(k) number is K232722.

When did endo.digital Platform receive FDA 510(k) clearance?

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

Who is the listed applicant for endo.digital Platform?

The FDA 510(k) record lists DreaMed Diabetes, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07599982Safety Evaluation of MODI, an Insulin Titration Algorithm, in Adults With DiabetesRECRUITING

Other records listing DreaMed Diabetes, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K210561Advisor Pro PlatformK201476DreaMed Advisor ProK191370DreaMed Advisor Pro

Related Devices (Code: QCC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑