DiviTum TKa
K-Number: K202852 · 2022-07-29
ApplicantBiovica International AB
Decision Date2022-07-29
Product CodeQTE
Advisory CommitteeIM
DecisionSubstantially Equivalent
Device Summary
DiviTum TKa is a medical device manufactured by Biovica International AB. It received FDA 510(k) clearance on 2022-07-29 under approval number K202852. The device is classified under product code QTE. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the DiviTum TKa?
DiviTum TKa is a medical device that received FDA 510(k) clearance on 2022-07-29. It is manufactured by Biovica International AB. The 510(k) number is K202852.
When was DiviTum TKa approved by the FDA?
DiviTum TKa received FDA 510(k) clearance on 2022-07-29, under approval number K202852.
What company makes DiviTum TKa?
DiviTum TKa is manufactured by Biovica International AB.
What is the FDA product code for DiviTum TKa?
The FDA product code for DiviTum TKa is QTE.
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.