Legend Pro DMA
K-Number: K200545 · 2021-10-21
ApplicantPollogen, Ltd.
Decision Date2021-10-21
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
Legend Pro DMA is a medical device manufactured by Pollogen, Ltd.. It received FDA 510(k) clearance on 2021-10-21 under approval number K200545. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Legend Pro DMA?
Legend Pro DMA is a medical device that received FDA 510(k) clearance on 2021-10-21. It is manufactured by Pollogen, Ltd.. The 510(k) number is K200545.
When was Legend Pro DMA approved by the FDA?
Legend Pro DMA received FDA 510(k) clearance on 2021-10-21, under approval number K200545.
What company makes Legend Pro DMA?
Legend Pro DMA is manufactured by Pollogen, Ltd..
What is the FDA product code for Legend Pro DMA?
The FDA product code for Legend Pro DMA is NGX.
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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.