WELL@HOME SYSTEM— 510(k) K040012

Substantially Equivalent

Zoe Medical, Inc.

FDA 510(k) clearance K040012 for WELL@HOME SYSTEM, Substantially Equivalent on 2004-04-02. Applicant: Zoe Medical, Inc..

Clearance details

Applicant: Zoe Medical, Inc.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2004-01-05
Decision date: 2004-04-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Topsfield, MA, 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.