Red Dot
K-Number: K191556 · 2020-02-28
ApplicantBehold.Ai Technologies Limited
Decision Date2020-02-28
Product CodeQFM
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Red Dot is a medical device manufactured by Behold.Ai Technologies Limited. It received FDA 510(k) clearance on 2020-02-28 under approval number K191556. The device is classified under product code QFM. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Red Dot?
Red Dot is a medical device that received FDA 510(k) clearance on 2020-02-28. It is manufactured by Behold.Ai Technologies Limited. The 510(k) number is K191556.
When was Red Dot approved by the FDA?
Red Dot received FDA 510(k) clearance on 2020-02-28, under approval number K191556.
What company makes Red Dot?
Red Dot is manufactured by Behold.Ai Technologies Limited.
What is the FDA product code for Red Dot?
The FDA product code for Red Dot is QFM.
Related Devices (Code: QFM)
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.