EQUAL DOSE 1.0— 510(k) K073273
Substantially EquivalentNucletron Corporation
FDA 510(k) clearance K073273 for EQUAL DOSE 1.0, Substantially Equivalent on 2007-12-11. Applicant: Nucletron Corporation.
Clearance details
- Applicant
- Nucletron Corporation
- Product code
- Code IYE
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Columbia, MD, 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.