FDA 510(k)

DEKA SIMON

K-Number: K232334 · 2023-09-01

Decision Date2023-09-01

Product CodeIPF

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

DEKA SIMON is the device name listed in this FDA 510(k) record. The listed applicant is El.En S.P.A.. It received FDA 510(k) clearance on 2023-09-01 under 510(k) 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. The listed applicant is El.En S.P.A.. The 510(k) number is K232334.

When did DEKA SIMON receive FDA 510(k) clearance?

DEKA SIMON received FDA 510(k) clearance on 2023-09-01, under 510(k) number K232334.

Who is the listed applicant for DEKA SIMON?

The FDA 510(k) record lists El.En S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DEKA SIMON?

The FDA product code for DEKA SIMON is IPF.

Other records listing El.En S.P.A. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.