DeviceClearance

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.. Device class: 2.

Clearance details

Applicant
Erika, Inc.
Product code
Code FJI
Device class
Class 2
Regulation
21 CFR 876.5820
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code FJI

product code FJI
Death
2
Total
2

Source: openFDA MAUDE database, through . 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.