NIDEK DIGITAL KERATOMETER— 510(k) K842892

Substantially Equivalent

Nidek, Inc.

FDA 510(k) clearance K842892 for NIDEK DIGITAL KERATOMETER, Substantially Equivalent on 1984-10-05. Applicant: Nidek, Inc..

Clearance details

Applicant: Nidek, Inc.
Product code: Code HQL
Advisory panel: Ophthalmic
Date received: 1984-07-23
Decision date: 1984-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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Adverse events under product code HQL

product code HQL

Injury: 7,145
Malfunction: 15,684
Other: 5
Total: 22,834

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.