K103796

Substantially Equivalent

TELEMEDCARE HEALTH MONITOR

Applicant: Telemedcare Pty, Ltd.
Product code: DRG
Advisory panel: Cardiovascular
Date received: 2010-12-27
Decision date: 2011-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rosebery, New South Wales, AU

Adverse events under product code DRG

product code DRG

Death: 5
Total: 5

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.