TOF-Cuff monitor— 510(k) K181894

Substantially Equivalent

Rgb Medical Devices SA

FDA 510(k) clearance K181894 for TOF-Cuff monitor, Substantially Equivalent on 2019-05-09. Applicant: Rgb Medical Devices SA.

Clearance details

Applicant: Rgb Medical Devices SA
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2018-07-16
Decision date: 2019-05-09
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Madrid, ES

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.