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FDA 510(k)

EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector)

K-Number: K190875 · 2019-09-25

ApplicantD.O.R.C. Dutch Ophthalmic Research Center (International)
Decision Date2019-09-25
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector) is a medical device manufactured by D.O.R.C. Dutch Ophthalmic Research Center (International). It received FDA 510(k) clearance on 2019-09-25 under approval number K190875. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector)?

EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector) is a medical device that received FDA 510(k) clearance on 2019-09-25. It is manufactured by D.O.R.C. Dutch Ophthalmic Research Center (International). The 510(k) number is K190875.

When was EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector) approved by the FDA?

EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector) received FDA 510(k) clearance on 2019-09-25, under approval number K190875.

What company makes EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector)?

EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector) is manufactured by D.O.R.C. Dutch Ophthalmic Research Center (International).

What is the FDA product code for EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector)?

The FDA product code for EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector) is HQC.

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Other Devices by D.O.R.C. Dutch Ophthalmic Research Center (International)

K213467EVA NEXUS Ophthalmic Surgical System

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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