ALTEX MODEL UST-3000E— 510(k) K924033

Substantially Equivalent

Optro-Mechanics (Usa) Corp.

FDA 510(k) clearance K924033 for ALTEX MODEL UST-3000E, Substantially Equivalent on 1992-11-05. Applicant: Optro-Mechanics (Usa) Corp..

Clearance details

Applicant: Optro-Mechanics (Usa) Corp.
Product code: Code HQC
Advisory panel: Ophthalmic
Date received: 1992-08-11
Decision date: 1992-11-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pearl River, NY, US

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Adverse events under product code HQC

product code HQC

Injury: 2,378
Malfunction: 8,768
Total: 11,146

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.