EVA,anterior machine, EVA, combined machine, EVA combined machine with laser(DORC connector), EVA combined machine with laser SMA connector)— 510(k) K142877
Substantially EquivalentDutch Ophthalmic Research Center International BV
FDA 510(k) clearance K142877 for EVA,anterior machine, EVA, combined machine, EVA combined machine with laser(DORC connector), EVA combined machine with laser SMA connector), Substantially Equivalent on 2015-03-13. Applicant: Dutch Ophthalmic Research Center International BV. Device class: 2.
Clearance details
- Applicant
- Dutch Ophthalmic Research Center International BV
- 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
- Zuidland, NL
Recent devices under product code HQC
view allMore clearances from Dutch Ophthalmic Research Center International BV
view allAdverse 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.