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FDA 510(k)

DreaMed Advisor Pro

K-Number: K201476 · 2020-08-28

ApplicantDreaMed Diabetes, Ltd.
Decision Date2020-08-28
Product CodeQCC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DreaMed Advisor Pro 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 2020-08-28 under 510(k) number K201476. 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 DreaMed Advisor Pro?

DreaMed Advisor Pro is a medical device that received FDA 510(k) clearance on 2020-08-28. The listed applicant is DreaMed Diabetes, Ltd.. The 510(k) number is K201476.

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

DreaMed Advisor Pro received FDA 510(k) clearance on 2020-08-28, under 510(k) number K201476.

Who is the listed applicant for DreaMed Advisor Pro?

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 DreaMed Advisor Pro?

The FDA product code for DreaMed Advisor Pro 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 PlatformK210561Advisor Pro PlatformK191370DreaMed 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.K210561Advisor Pro PlatformDreaMed 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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