FRESENIUS HAEMODIALYSIS; MACHINE A1008— 510(k) K844641

Name: FDA 510(k) clearance K844641
Creator: U.S. Food and Drug Administration
Published: 1985-02-14

Substantially Equivalent

Seratronics, Inc.

FDA 510(k) clearance K844641 for FRESENIUS HAEMODIALYSIS; MACHINE A1008, Substantially Equivalent on 1985-02-14. Applicant: Seratronics, Inc.. Device class: 2.

Clearance details

Device name as filed: FRESENIUS HAEMODIALYSIS ;MACHINE A1008
Applicant: Seratronics, Inc.
Product code: Code FKQ
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1984-11-28
Decision date: 1985-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Concord, CA, 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.