CONCENTRATE CONDUCTIVITY METER— 510(k) K841543

Name: FDA 510(k) clearance K841543
Creator: U.S. Food and Drug Administration
Published: 1984-05-22

Substantially Equivalent

Renal Systems, Inc.

FDA 510(k) clearance K841543 for CONCENTRATE CONDUCTIVITY METER, Substantially Equivalent on 1984-05-22. Applicant: Renal Systems, Inc.. Device class: 2.

Clearance details

Applicant: Renal Systems, Inc.
Product code: Code FKQ
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1984-04-16
Decision date: 1984-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FKQ

product code FKQ

Other: 1
Total: 1

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.