HORIZON 2000 ST ANALYSIS OPTION— 510(k) K903524

Substantially Equivalent

Mennen Medical, Inc.

FDA 510(k) clearance K903524 for HORIZON 2000 ST ANALYSIS OPTION, Substantially Equivalent on 1991-03-01. Applicant: Mennen Medical, Inc..

Clearance details

Applicant: Mennen Medical, Inc.
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 1990-08-06
Decision date: 1991-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clarence, NY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

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.