XTRA4
K-Number: K251320 · 2025-09-11
ApplicantAl.Chi.Mi.A. S.R.L
Decision Date2025-09-11
Product CodeLYX
DecisionSubstantially Equivalent
Device Summary
XTRA4 is a medical device manufactured by Al.Chi.Mi.A. S.R.L. It received FDA 510(k) clearance on 2025-09-11 under approval number K251320. The device is classified under product code LYX. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the XTRA4?
XTRA4 is a medical device that received FDA 510(k) clearance on 2025-09-11. It is manufactured by Al.Chi.Mi.A. S.R.L. The 510(k) number is K251320.
When was XTRA4 approved by the FDA?
XTRA4 received FDA 510(k) clearance on 2025-09-11, under approval number K251320.
What company makes XTRA4?
XTRA4 is manufactured by Al.Chi.Mi.A. S.R.L.
What is the FDA product code for XTRA4?
The FDA product code for XTRA4 is LYX.
Other Devices by Al.Chi.Mi.A. S.R.L
Related Devices (Code: LYX)
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.