HOMMED OBSERVER, MODEL I— 510(k) K003180

Substantially Equivalent

Hommed, LLC

FDA 510(k) clearance K003180 for HOMMED OBSERVER, MODEL I, Substantially Equivalent on 2001-06-28. Applicant: Hommed, LLC.

Clearance details

Applicant: Hommed, LLC
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2000-10-11
Decision date: 2001-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXN

product code DXN

Death: 3
Injury: 169
Malfunction: 1,019
Other: 2
Total: 1,193

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.