Legend X Desktop System
K-Number: K243217 · 2024-11-01
ApplicantPollogen, Ltd.
Decision Date2024-11-01
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Legend X Desktop System is a medical device manufactured by Pollogen, Ltd.. It received FDA 510(k) clearance on 2024-11-01 under approval number K243217. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Legend X Desktop System?
Legend X Desktop System is a medical device that received FDA 510(k) clearance on 2024-11-01. It is manufactured by Pollogen, Ltd.. The 510(k) number is K243217.
When was Legend X Desktop System approved by the FDA?
Legend X Desktop System received FDA 510(k) clearance on 2024-11-01, under approval number K243217.
What company makes Legend X Desktop System?
Legend X Desktop System is manufactured by Pollogen, Ltd..
What is the FDA product code for Legend X Desktop System?
The FDA product code for Legend X Desktop System is GEI.
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Official Source
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