510(k) K843487— VISITEC OPHTHALMIC FLUID DISTRIB- SET

Substantially Equivalent

Visitec Co.

Clearance details

Applicant: Visitec Co.
Product code: Code HQC
Advisory panel: Ophthalmic
Date received: 1984-09-06
Decision date: 1985-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sarasota, FL, US

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.