StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2
K-Number: K212103 · 2021-08-30
ApplicantFona S.R.L
Decision Date2021-08-30
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2 is a medical device manufactured by Fona S.R.L. It received FDA 510(k) clearance on 2021-08-30 under approval number K212103. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2?
StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2 is a medical device that received FDA 510(k) clearance on 2021-08-30. It is manufactured by Fona S.R.L. The 510(k) number is K212103.
When was StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2 approved by the FDA?
StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2 received FDA 510(k) clearance on 2021-08-30, under approval number K212103.
What company makes StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2?
StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2 is manufactured by Fona S.R.L.
What is the FDA product code for StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2?
The FDA product code for StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2 is MUH.
Other Devices by Fona S.R.L
Related Devices (Code: MUH)
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.