A-18 HEMODIALYZER— 510(k) K992565

Substantially Equivalent

Althin Medical AB

FDA 510(k) clearance K992565 for A-18 HEMODIALYZER, Substantially Equivalent on 1999-09-23. Applicant: Althin Medical AB.

Clearance details

Applicant: Althin Medical AB
Product code: Code FJI
Advisory panel: Gastroenterology, Urology
Date received: 1999-08-02
Decision date: 1999-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ronneby, SE

Download summary PDF View on FDA.gov ↗

Adverse events under product code FJI

product code FJI

Death: 2
Total: 2

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.