DOSE 1— 510(k) K000209
Substantially EquivalentScanditronix Wellhofer North America
FDA 510(k) clearance K000209 for DOSE 1, Substantially Equivalent on 2000-08-18. Applicant: Scanditronix Wellhofer North America.
Clearance details
- Applicant
- Scanditronix Wellhofer North America
- Product code
- Code IYE
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bartlett, TN, US
Adverse 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.