R.L. MEDICAL TWIN LIGHT SOURCE— 510(k) K842609

Name: FDA 510(k) clearance K842609
Creator: U.S. Food and Drug Administration
Published: 1984-08-09

Substantially Equivalent

Tridak Division of Indicon, Inc.

FDA 510(k) clearance K842609 for R.L. MEDICAL TWIN LIGHT SOURCE, Substantially Equivalent on 1984-08-09. Applicant: Tridak Division of Indicon, Inc.. Device class: 2.

Clearance details

Applicant: Tridak Division of Indicon, Inc.
Product code: Code FCW
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1984-07-05
Decision date: 1984-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FCW

product code FCW

Malfunction: 912
Other: 1
Total: 913

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.