Deka Tiac II— 510(k) K211091

Substantially Equivalent

El.En Electronic Engineering Spa

FDA 510(k) clearance K211091 for Deka Tiac II, Substantially Equivalent on 2021-10-15. Applicant: El.En Electronic Engineering Spa. Device class: 2.

Clearance details

Applicant: El.En Electronic Engineering Spa
Product code: Code PBX
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2021-04-12
Decision date: 2021-10-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Calenzano, IT

Download summary PDF View on FDA.gov ↗

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