LEONI ORION System
K-Number: K160518 · 2016-07-14
ApplicantLeoni Cia Cable System
Decision Date2016-07-14
Product CodeJAI
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
LEONI ORION System is a medical device manufactured by Leoni Cia Cable System. It received FDA 510(k) clearance on 2016-07-14 under approval number K160518. The device is classified under product code JAI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the LEONI ORION System?
LEONI ORION System is a medical device that received FDA 510(k) clearance on 2016-07-14. It is manufactured by Leoni Cia Cable System. The 510(k) number is K160518.
When was LEONI ORION System approved by the FDA?
LEONI ORION System received FDA 510(k) clearance on 2016-07-14, under approval number K160518.
What company makes LEONI ORION System?
LEONI ORION System is manufactured by Leoni Cia Cable System.
What is the FDA product code for LEONI ORION System?
The FDA product code for LEONI ORION System is JAI.
Related Clinical Trials
Related Devices (Code: JAI)
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.