ULTRACON ULTRAFILTRATOR— 510(k) K971710

Name: FDA 510(k) clearance K971710
Creator: U.S. Food and Drug Administration
Published: 1998-02-27

Substantially Equivalent

Quantic Biomedical, Inc.

FDA 510(k) clearance K971710 for ULTRACON ULTRAFILTRATOR, Substantially Equivalent on 1998-02-27. Applicant: Quantic Biomedical, Inc.. Device class: 2.

Clearance details

Applicant: Quantic Biomedical, Inc.
Product code: Code FJI
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1997-05-08
Decision date: 1998-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Rafael, CA, US

Download summary PDF View on FDA.gov ↗

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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.