DEKA SIMON— 510(k) K232334

Substantially Equivalent

El.En S.P.A.

FDA 510(k) clearance K232334 for DEKA SIMON, Substantially Equivalent on 2023-09-01. Applicant: El.En S.P.A.. Device class: 2.

Clearance details

Applicant
El.En S.P.A.
Product code
Code IPF
Device class
Class 2
Regulation
21 CFR 890.5850
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Calenzano, IT
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Data sourced from openFDA. This site is unofficial and independent of the FDA.