ARCO FP-S— 510(k) K211777
Substantially EquivalentA.T.S. Applicazione Tecnologie Speciali S.R.L.
FDA 510(k) clearance K211777 for ARCO FP-S, Substantially Equivalent on 2021-08-13. Applicant: A.T.S. Applicazione Tecnologie Speciali S.R.L..
Clearance details
- Applicant
- A.T.S. Applicazione Tecnologie Speciali S.R.L.
- Product code
- Code OWB
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Torre De Roveri, IT
Adverse events under product code OWB
product code OWB- Death
- 49
- Injury
- 340
- Malfunction
- 36,973
- Total
- 37,362
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.