Opera Swing

by General Medical Merate S.P.A. Italy 510(k)

510(k) K140380

Product code JAA

Regulatory status

as of 25 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK140380	Date26 Sep 2014Cleared	StatusActive

Coverage

1 jurisdiction

Active
Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

510(k) Number: K140380
FDA Product Code: JAA
FDA applicant: General Medical Merate S.P.A

Device Class: Class II
Regulation: 21 CFR Part 892.1650
Advisory Committee: Radiology
FDA Decision: SESE Substantially Equivalent

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Properties & raw data

Show properties, registry sources and raw records

Sources (1)

FDA 510(k) K140380 24 fields · synced 22 Oct 2026