MODIFICATION TO HEALTH BUDDY WITH DEVICE CONNECTIVITY— 510(k) K042273

Substantially Equivalent

Health Hero Network, Inc.

FDA 510(k) clearance K042273 for MODIFICATION TO HEALTH BUDDY WITH DEVICE CONNECTIVITY, Substantially Equivalent on 2004-08-31. Applicant: Health Hero Network, Inc..

Clearance details

Applicant: Health Hero Network, Inc.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2004-08-23
Decision date: 2004-08-31
Decision: Substantially Equivalent
Clearance type: Special
Location: Mountain View, CA, 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.