K896755
Substantially EquivalentALOKA 680 DIAGNOSTIC ULTRASOUND SCANNING SYSTEM
- Applicant
- Ge Medical Systems Information Technologies
- Product code
- IYO
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wallingford, CT, 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.