EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector)— 510(k) K190875
Substantially EquivalentD.O.R.C. Dutch Ophthalmic Research Center (International)
FDA 510(k) clearance K190875 for EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector), Substantially Equivalent on 2019-09-25. Applicant: D.O.R.C. Dutch Ophthalmic Research Center (International). Device class: 2.
Clearance details
- Applicant
- D.O.R.C. Dutch Ophthalmic Research Center (International)
- Product code
- 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
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More clearances from D.O.R.C. Dutch Ophthalmic Research Center (International)
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 →
Recalls naming K190875
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K190875.
Data sourced from openFDA. This site is unofficial and independent of the FDA.