OPERA SWING— 510(k) K140380
Substantially EquivalentGeneral 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.
Clearance details
- Applicant
- General Medical Merate S.P.A
- Product code
- Code JAA
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ormond Beach, FL, US
Adverse events under product code JAA
product code JAA- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . 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.