MARCH HEALTHCARE HEALTH MONITORING KIT— 510(k) K060194

Substantially Equivalent

March Healthcare Corporation

FDA 510(k) clearance K060194 for MARCH HEALTHCARE HEALTH MONITORING KIT, Substantially Equivalent on 2006-02-13. Applicant: March Healthcare Corporation.

Clearance details

Applicant: March Healthcare Corporation
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2006-01-25
Decision date: 2006-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ottawa, Ontario, CA

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.