INFINITI VISION SYSTEM WITH OZIL IP— 510(k) K082845
Substantially EquivalentAlcon Research, Ltd.
FDA 510(k) clearance K082845 for INFINITI VISION SYSTEM WITH OZIL IP, Substantially Equivalent on 2009-02-12. Applicant: Alcon Research, Ltd.. Device class: 2.
Clearance details
- Applicant
- Alcon Research, Ltd.
- Product code
- Product code HQC
- Device class
- Class 2
- Regulation
- 21 CFR 886.4670
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fort Worth, TX, US
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Adverse events under product code HQC
product code HQC- Injury
- 2,378
- Malfunction
- 8,768
- Total
- 11,146
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.