ELDONCARD— 510(k) K790282

Substantially Equivalent

Nordisk Infuser System

FDA 510(k) clearance K790282 for ELDONCARD, Substantially Equivalent on 1979-05-04. Applicant: Nordisk Infuser System.

Clearance details

Applicant: Nordisk Infuser System
Product code: Code KSZ
Advisory panel: Hematology
Date received: 1979-02-13
Decision date: 1979-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KSZ

product code KSZ

Malfunction: 517
Total: 517

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.