EUB-410 DIAGNOSTIC ULTRASOUND DEVICE— 510(k) K871004
Substantially EquivalentHitachi Medical Corp. of America
FDA 510(k) clearance K871004 for EUB-410 DIAGNOSTIC ULTRASOUND DEVICE, Substantially Equivalent on 1987-12-11. Applicant: Hitachi Medical Corp. of America. Device class: 2.
Clearance details
- Applicant
- Hitachi Medical Corp. of America
- Product code
- Code IYO
- Device class
- Class 2
- Regulation
- 21 CFR 892.1560
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tarrytown, NY, US
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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.