RTX3320PSTN WIRELESS TELEHEALTH GATEWAY— 510(k) K041816

Name: FDA 510(k) clearance K041816
Creator: U.S. Food and Drug Administration
Published: 2004-07-19

Substantially Equivalent

Rtx Healthcare A/S

FDA 510(k) clearance K041816 for RTX3320PSTN WIRELESS TELEHEALTH GATEWAY, Substantially Equivalent on 2004-07-19. Applicant: Rtx Healthcare A/S. Device class: 2.

Clearance details

Applicant: Rtx Healthcare A/S
Product code: Code DRG
Device class: Class 2
Regulation: 21 CFR 870.2910
Advisory panel: Cardiovascular
Date received: 2004-07-06
Decision date: 2004-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Noerresundby, DK

Download summary PDF View on FDA.gov ↗

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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.