HORIZON DISPLAY CONTROLLER PART # 266-200-010— 510(k) K884423

Name: FDA 510(k) clearance K884423
Creator: U.S. Food and Drug Administration
Published: 1989-05-31

Substantially Equivalent

Mennen Medical, Inc.

FDA 510(k) clearance K884423 for HORIZON DISPLAY CONTROLLER PART # 266-200-010, Substantially Equivalent on 1989-05-31. Applicant: Mennen Medical, Inc.. Device class: 2.

Clearance details

Applicant: Mennen Medical, Inc.
Product code: Code DXJ
Device class: Class 2
Regulation: 21 CFR 870.2450
Advisory panel: Cardiovascular
Date received: 1988-10-19
Decision date: 1989-05-31
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 DXJ

product code DXJ

Death: 2
Total: 2

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.