CLISIS SYSTEMS, Discovery RF180— 510(k) K213081

Name: FDA 510(k) clearance K213081
Creator: U.S. Food and Drug Administration
Published: 2021-10-26

Substantially Equivalent

General Medical Merate S.P.A

FDA 510(k) clearance K213081 for CLISIS SYSTEMS, Discovery RF180, Substantially Equivalent on 2021-10-26. Applicant: General Medical Merate S.P.A. Device class: 2.

Clearance details

Applicant: General Medical Merate S.P.A
Product code: Code IZF
Device class: Class 2
Regulation: 21 CFR 892.1740
Advisory panel: Radiology
Date received: 2021-09-23
Decision date: 2021-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seriate, IT

Download summary PDF View on FDA.gov ↗

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