DEKA PHYSIQ 360— 510(k) K231971

Substantially Equivalent

El.En S.P.A.

FDA 510(k) clearance K231971 for DEKA PHYSIQ 360, Substantially Equivalent on 2023-09-26. Applicant: El.En S.P.A.. Device class: 2.

Clearance details

Applicant
El.En S.P.A.
Product code
Code PKT
Device class
Class 2
Regulation
21 CFR 878.5400
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Calenzano, IT
Download summary PDFView on FDA.gov ↗

Recent devices under product code PKT

view all

More clearances from El.En S.P.A.

view all

Data sourced from openFDA. This site is unofficial and independent of the FDA.