ERIKA HPF 100,200,300 DIALYZER— 510(k) K821690

Substantially Equivalent

Erika, Inc.

FDA 510(k) clearance K821690 for ERIKA HPF 100,200,300 DIALYZER, Substantially Equivalent on 1982-06-22. Applicant: Erika, Inc..

Clearance details

Applicant: Erika, Inc.
Product code: Code FJI
Advisory panel: Gastroenterology, Urology
Date received: 1982-06-08
Decision date: 1982-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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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.