ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X— 510(k) K991512

Substantially Equivalent

Asahi Medical Co., Ltd.

FDA 510(k) clearance K991512 for ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X, Substantially Equivalent on 1999-07-29. Applicant: Asahi Medical Co., Ltd..

Clearance details

Applicant: Asahi Medical Co., Ltd.
Product code: Code FJI
Advisory panel: Gastroenterology, Urology
Date received: 1999-04-30
Decision date: 1999-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, US

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.