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FDA 510(k)

Advisor Pro Platform

K-Number: K210561 · 2021-09-28

ApplicantDreaMed Diabetes, Ltd.
Decision Date2021-09-28
Product CodeQCC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Advisor Pro 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 2021-09-28 under 510(k) number K210561. 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 Advisor Pro Platform?

Advisor Pro Platform is a medical device that received FDA 510(k) clearance on 2021-09-28. The listed applicant is DreaMed Diabetes, Ltd.. The 510(k) number is K210561.

When did Advisor Pro Platform receive FDA 510(k) clearance?

Advisor Pro Platform received FDA 510(k) clearance on 2021-09-28, under 510(k) number K210561.

Who is the listed applicant for Advisor Pro 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 Advisor Pro Platform?

The FDA product code for Advisor Pro 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.

K232722endo.digital 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.

K232722endo.digital PlatformDreaMed Diabetes, Ltd.K201476DreaMed Advisor ProDreaMed Diabetes, Ltd.K191370DreaMed Advisor ProDreaMed Diabetes, Ltd.

Official Source

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

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