ri-former Predictive Thermometer— 510(k) K171182

Substantially Equivalent

Rudolf Riester GmbH

FDA 510(k) clearance K171182 for ri-former Predictive Thermometer, Substantially Equivalent on 2017-10-04. Applicant: Rudolf Riester GmbH.

Clearance details

Applicant: Rudolf Riester GmbH
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2017-04-24
Decision date: 2017-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Junginge, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code FLL

product code FLL

Death: 3
Malfunction: 557
Total: 560

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.