VISION TWO, ONE/10 ONE/20 &24— 510(k) K832895

Name: FDA 510(k) clearance K832895
Creator: U.S. Food and Drug Administration
Published: 1983-12-08

Substantially Equivalent

Comtal Corp.

FDA 510(k) clearance K832895 for VISION TWO, ONE/10 ONE/20 &24, Substantially Equivalent on 1983-12-08. Applicant: Comtal Corp.. Device class: 2.

Clearance details

Applicant: Comtal Corp.
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 1983-08-26
Decision date: 1983-12-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLZ

view all

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.