CoreLevee
K-Number: K213748 · 2022-10-14
ApplicantLutronic Corporation
Decision Date2022-10-14
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
CoreLevee is a medical device manufactured by Lutronic Corporation. It received FDA 510(k) clearance on 2022-10-14 under approval number K213748. 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 CoreLevee?
CoreLevee is a medical device that received FDA 510(k) clearance on 2022-10-14. It is manufactured by Lutronic Corporation. The 510(k) number is K213748.
When was CoreLevee approved by the FDA?
CoreLevee received FDA 510(k) clearance on 2022-10-14, under approval number K213748.
What company makes CoreLevee?
CoreLevee is manufactured by Lutronic Corporation.
What is the FDA product code for CoreLevee?
The FDA product code for CoreLevee 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.