OPERA SWING— 510(k) K140380

Name: FDA 510(k) clearance K140380
Creator: U.S. Food and Drug Administration
Published: 2014-09-26

Substantially Equivalent

General Medical Merate S.P.A

FDA 510(k) clearance K140380 for OPERA SWING, Substantially Equivalent on 2014-09-26. Applicant: General Medical Merate S.P.A. Device class: 2.

Clearance details

Applicant: General Medical Merate S.P.A
Product code: Code JAA
Device class: Class 2
Regulation: 21 CFR 892.1650
Advisory panel: Radiology
Date received: 2014-02-14
Decision date: 2014-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ormond Beach, FL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code JAA

product code JAA

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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