STYROFOAM CUTTERS FOR BLOCK CASTING SYSTEM— 510(k) K010062
Substantially EquivalentArplay Medical S.A.
FDA 510(k) clearance K010062 for STYROFOAM CUTTERS FOR BLOCK CASTING SYSTEM, Substantially Equivalent on 2001-03-13. Applicant: Arplay Medical S.A.. Device class: 2.
Clearance details
- Applicant
- Arplay Medical S.A.
- Product code
- Code IYE
- Device class
- Class 2
- Regulation
- 21 CFR 892.5050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Izeure, Cote D'Or, FR
Recent devices under product code IYE
view allMore clearances from Arplay Medical S.A.
view allAdverse events under product code IYE
product code IYE- Malfunction
- 455
- Other
- 3
- Total
- 458
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.