GE LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS 5205000, 5205000-2— 510(k) K082185
Substantially EquivalentGe Medical Systems Ultrasound and Primary Care Dia
FDA 510(k) clearance K082185 for GE LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS 5205000, 5205000-2, Substantially Equivalent on 2008-08-15. Applicant: Ge Medical Systems Ultrasound and Primary Care Dia.
Clearance details
- Applicant
- Ge Medical Systems Ultrasound and Primary Care Dia
- Product code
- Code IYO
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Wauwatosa, WI, 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.