14 COLOR VIDEO DISPLAY 211-260-010— 510(k) K893585

Name: FDA 510(k) clearance K893585
Creator: U.S. Food and Drug Administration
Published: 1989-07-20

Substantially Equivalent

Mennen Medical, Inc.

FDA 510(k) clearance K893585 for 14 COLOR VIDEO DISPLAY 211-260-010, Substantially Equivalent on 1989-07-20. Applicant: Mennen Medical, Inc.. Device class: 2.

Clearance details

Applicant: Mennen Medical, Inc.
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 1989-05-09
Decision date: 1989-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clarence, NY, US

Download summary PDF View on FDA.gov ↗

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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.