HORIZON 2000 FRACTION OF INSPIRED OXYGEN MON. CAP.— 510(k) K894918

Substantially Equivalent

Mennen Medical, Inc.

FDA 510(k) clearance K894918 for HORIZON 2000 FRACTION OF INSPIRED OXYGEN MON. CAP., Substantially Equivalent on 1989-10-31. Applicant: Mennen Medical, Inc..

Clearance details

Applicant: Mennen Medical, Inc.
Product code: Code CCL
Advisory panel: Anesthesiology
Date received: 1989-08-02
Decision date: 1989-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clarence, NY, US

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Adverse events under product code CCL

product code CCL

Other: 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.