Helianthus
K-Number: K202822 · 2021-12-15
ApplicantMetaltronica Spa
Decision Date2021-12-15
Product CodeMUE
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Helianthus is a medical device manufactured by Metaltronica Spa. It received FDA 510(k) clearance on 2021-12-15 under approval number K202822. The device is classified under product code MUE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Helianthus?
Helianthus is a medical device that received FDA 510(k) clearance on 2021-12-15. It is manufactured by Metaltronica Spa. The 510(k) number is K202822.
When was Helianthus approved by the FDA?
Helianthus received FDA 510(k) clearance on 2021-12-15, under approval number K202822.
What company makes Helianthus?
Helianthus is manufactured by Metaltronica Spa.
What is the FDA product code for Helianthus?
The FDA product code for Helianthus is MUE.
Related Devices (Code: MUE)
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.