ELECTRONIC ULTRASOUND SCANNER, MODEL EUB-340— 510(k) K862165
Substantially EquivalentHitachi Medical Corp. of America
FDA 510(k) clearance K862165 for ELECTRONIC ULTRASOUND SCANNER, MODEL EUB-340, Substantially Equivalent on 1986-11-28. Applicant: Hitachi Medical Corp. of America.
Clearance details
- Applicant
- Hitachi Medical Corp. of America
- Product code
- Code IYO
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tarrytown, NY, 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.