Ellusa Reusable Neutral Plates
K-Number: K222425 · 2022-09-08
ApplicantEllusa, LLC
Decision Date2022-09-08
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Ellusa Reusable Neutral Plates is a medical device manufactured by Ellusa, LLC. It received FDA 510(k) clearance on 2022-09-08 under approval number K222425. 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 Ellusa Reusable Neutral Plates?
Ellusa Reusable Neutral Plates is a medical device that received FDA 510(k) clearance on 2022-09-08. It is manufactured by Ellusa, LLC. The 510(k) number is K222425.
When was Ellusa Reusable Neutral Plates approved by the FDA?
Ellusa Reusable Neutral Plates received FDA 510(k) clearance on 2022-09-08, under approval number K222425.
What company makes Ellusa Reusable Neutral Plates?
Ellusa Reusable Neutral Plates is manufactured by Ellusa, LLC.
What is the FDA product code for Ellusa Reusable Neutral Plates?
The FDA product code for Ellusa Reusable Neutral Plates is GEI.
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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.