Agilon Moldable
K-Number: K193168 · 2020-02-13
ApplicantBiogennix, LLC
Decision Date2020-02-13
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Agilon Moldable is a medical device manufactured by Biogennix, LLC. It received FDA 510(k) clearance on 2020-02-13 under approval number K193168. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Agilon Moldable?
Agilon Moldable is a medical device that received FDA 510(k) clearance on 2020-02-13. It is manufactured by Biogennix, LLC. The 510(k) number is K193168.
When was Agilon Moldable approved by the FDA?
Agilon Moldable received FDA 510(k) clearance on 2020-02-13, under approval number K193168.
What company makes Agilon Moldable?
Agilon Moldable is manufactured by Biogennix, LLC.
What is the FDA product code for Agilon Moldable?
The FDA product code for Agilon Moldable is MQV.
Other Devices by Biogennix, LLC
Related Devices (Code: MQV)
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.