Geneo X Elite
K-Number: K233766 · 2024-05-07
ApplicantPollogen, Ltd.
Decision Date2024-05-07
Product CodePAY
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Geneo X Elite is a medical device manufactured by Pollogen, Ltd.. It received FDA 510(k) clearance on 2024-05-07 under approval number K233766. The device is classified under product code PAY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Geneo X Elite?
Geneo X Elite is a medical device that received FDA 510(k) clearance on 2024-05-07. It is manufactured by Pollogen, Ltd.. The 510(k) number is K233766.
When was Geneo X Elite approved by the FDA?
Geneo X Elite received FDA 510(k) clearance on 2024-05-07, under approval number K233766.
What company makes Geneo X Elite?
Geneo X Elite is manufactured by Pollogen, Ltd..
What is the FDA product code for Geneo X Elite?
The FDA product code for Geneo X Elite is PAY.
Other Devices by Pollogen, Ltd.
Related Devices (Code: PAY)
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.