AXIS NANO OPTHALMIC BIOMETER ULTRASOUND SYSTEM— 510(k) K102027
Substantially EquivalentQuantel Medical S.A.
FDA 510(k) clearance K102027 for AXIS NANO OPTHALMIC BIOMETER ULTRASOUND SYSTEM, Substantially Equivalent on 2010-12-22. Applicant: Quantel Medical S.A..
Clearance details
- Applicant
- Quantel Medical S.A.
- Product code
- Code IYO
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bozeman, MT, 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.