BASIC, MODELS BASIC 1, BASIC 2, AND BASIC 3— 510(k) K012369
Substantially EquivalentAtys Medical
FDA 510(k) clearance K012369 for BASIC, MODELS BASIC 1, BASIC 2, AND BASIC 3, Substantially Equivalent on 2001-08-10. Applicant: Atys Medical.
Clearance details
- Applicant
- Atys Medical
- Product code
- Code IYN
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Soucieu En Jarrest, FR
Adverse events under product code IYN
product code IYN- Death
- 25
- Injury
- 163
- Malfunction
- 1,538
- Other
- 4
- Total
- 1,730
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.