DreaMed Advisor Pro
K-Number: K191370 · 2019-07-18
ApplicantDreaMed Diabetes, Ltd.
Decision Date2019-07-18
Product CodeQCC
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
DreaMed Advisor Pro is a medical device manufactured by DreaMed Diabetes, Ltd.. It received FDA 510(k) clearance on 2019-07-18 under approval number K191370. 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 2019-07-18. It is manufactured by DreaMed Diabetes, Ltd.. The 510(k) number is K191370.
When was DreaMed Advisor Pro approved by the FDA?
DreaMed Advisor Pro received FDA 510(k) clearance on 2019-07-18, under approval number K191370.
What company makes DreaMed Advisor Pro?
DreaMed Advisor Pro is manufactured by DreaMed Diabetes, Ltd..
What is the FDA product code for DreaMed Advisor Pro?
The FDA product code for DreaMed Advisor Pro is QCC.
Other Devices by DreaMed Diabetes, Ltd.
Related Devices (Code: QCC)
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.