qER
K-Number: K200921 · 2020-06-17
ApplicantQure.Ai Technologies
Decision Date2020-06-17
Product CodeQAS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
qER is a medical device manufactured by Qure.Ai Technologies. It received FDA 510(k) clearance on 2020-06-17 under approval number K200921. The device is classified under product code QAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the qER?
qER is a medical device that received FDA 510(k) clearance on 2020-06-17. It is manufactured by Qure.Ai Technologies. The 510(k) number is K200921.
When was qER approved by the FDA?
qER received FDA 510(k) clearance on 2020-06-17, under approval number K200921.
What company makes qER?
qER is manufactured by Qure.Ai Technologies.
What is the FDA product code for qER?
The FDA product code for qER is QAS.
Other Devices by Qure.Ai Technologies
Related Devices (Code: QAS)
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.