RVS-100 Vital Signs Monitor— 510(k) K170538

Substantially Equivalent

Rudolf Riester GmbH

FDA 510(k) clearance K170538 for RVS-100 Vital Signs Monitor, Substantially Equivalent on 2017-10-17. Applicant: Rudolf Riester GmbH.

Clearance details

Applicant: Rudolf Riester GmbH
Product code: Code MWI
Advisory panel: Cardiovascular
Date received: 2017-02-23
Decision date: 2017-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jungingen, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code MWI

product code MWI

Death: 16
Malfunction: 963
Total: 979

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.