DEKA SIMON
K-Number: K232334 · 2023-09-01
ApplicantEl.En S.P.A.
Decision Date2023-09-01
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
DEKA SIMON is a medical device manufactured by El.En S.P.A.. It received FDA 510(k) clearance on 2023-09-01 under approval number K232334. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the DEKA SIMON?
DEKA SIMON is a medical device that received FDA 510(k) clearance on 2023-09-01. It is manufactured by El.En S.P.A.. The 510(k) number is K232334.
When was DEKA SIMON approved by the FDA?
DEKA SIMON received FDA 510(k) clearance on 2023-09-01, under approval number K232334.
What company makes DEKA SIMON?
DEKA SIMON is manufactured by El.En S.P.A..
What is the FDA product code for DEKA SIMON?
The FDA product code for DEKA SIMON is IPF.
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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.