K041816

Substantially Equivalent

RTX3320PSTN WIRELESS TELEHEALTH GATEWAY

Applicant: Rtx Healthcare A/S
Product code: DRG
Advisory panel: Cardiovascular
Date received: 2004-07-06
Decision date: 2004-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Noerresundby, DK

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.