OPD-STATION SOFTWARE— 510(k) K050336

Name: FDA 510(k) clearance K050336
Creator: U.S. Food and Drug Administration
Published: 2005-08-24

Substantially Equivalent

Nidek, Inc.

FDA 510(k) clearance K050336 for OPD-STATION SOFTWARE, Substantially Equivalent on 2005-08-24. Applicant: Nidek, Inc.. Device class: 1.

Clearance details

Applicant: Nidek, Inc.
Product code: Code NCF
Device class: Class 1
Regulation: 21 CFR 886.1760
Advisory panel: Ophthalmic
Date received: 2005-02-10
Decision date: 2005-08-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Forest, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code NCF

product code NCF

Injury: 129
Total: 129

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.