HUDSON 2020, 2040, 2060,ULTRASOUND SCANNERS— 510(k) K022928
Substantially EquivalentHudson Diagnostic Imaging, LLC
FDA 510(k) clearance K022928 for HUDSON 2020, 2040, 2060,ULTRASOUND SCANNERS, Substantially Equivalent on 2002-12-11. Applicant: Hudson Diagnostic Imaging, LLC.
Clearance details
- Applicant
- Hudson Diagnostic Imaging, LLC
- Product code
- Code IYO
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Elmwood Park, NJ, US
Adverse events under product code IYO
product code IYO- Malfunction
- 3,339
- Total
- 3,339
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.