PRECISA— 510(k) K925294

Substantially Equivalent

Rudolf Riester GmbH & Co. KG

FDA 510(k) clearance K925294 for PRECISA, Substantially Equivalent on 1994-02-23. Applicant: Rudolf Riester GmbH & Co. KG.

Clearance details

Applicant: Rudolf Riester GmbH & Co. KG
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 1992-10-21
Decision date: 1994-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: D-72417 Jungingen, DE

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.