Inion BioRestore
K-Number: K191764 · 2019-07-31
ApplicantInion OY
Decision Date2019-07-31
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Inion BioRestore is a medical device manufactured by Inion OY. It received FDA 510(k) clearance on 2019-07-31 under approval number K191764. 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 Inion BioRestore?
Inion BioRestore is a medical device that received FDA 510(k) clearance on 2019-07-31. It is manufactured by Inion OY. The 510(k) number is K191764.
When was Inion BioRestore approved by the FDA?
Inion BioRestore received FDA 510(k) clearance on 2019-07-31, under approval number K191764.
What company makes Inion BioRestore?
Inion BioRestore is manufactured by Inion OY.
What is the FDA product code for Inion BioRestore?
The FDA product code for Inion BioRestore is MQV.
Other Devices by Inion OY
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.