JMS DIALYZER PRIMING SET— 510(k) K983707

Substantially Equivalent

Jms Co., Ltd.

FDA 510(k) clearance K983707 for JMS DIALYZER PRIMING SET, Substantially Equivalent on 1999-01-08. Applicant: Jms Co., Ltd..

Clearance details

Applicant: Jms Co., Ltd.
Product code: Code KOC
Advisory panel: Gastroenterology, Urology
Date received: 1998-10-21
Decision date: 1999-01-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hiroshima, JP

Download summary PDF View on FDA.gov ↗

Adverse events under product code KOC

product code KOC

Death: 4
Total: 4

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.