DEKA LOTUS
K-Number: K250281 · 2025-02-26
ApplicantEl.En S.P.A.
Decision Date2025-02-26
Product CodeONF
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
DEKA LOTUS is a medical device manufactured by El.En S.P.A.. It received FDA 510(k) clearance on 2025-02-26 under approval number K250281. The device is classified under product code ONF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the DEKA LOTUS?
DEKA LOTUS is a medical device that received FDA 510(k) clearance on 2025-02-26. It is manufactured by El.En S.P.A.. The 510(k) number is K250281.
When was DEKA LOTUS approved by the FDA?
DEKA LOTUS received FDA 510(k) clearance on 2025-02-26, under approval number K250281.
What company makes DEKA LOTUS?
DEKA LOTUS is manufactured by El.En S.P.A..
What is the FDA product code for DEKA LOTUS?
The FDA product code for DEKA LOTUS is ONF.
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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.