BEDSIDE CONSOLES (11-3-910 & 11-3-930)— 510(k) K760965

Name: FDA 510(k) clearance K760965
Creator: U.S. Food and Drug Administration
Published: 1976-12-06

Substantially Equivalent

Seattle Artificial Kidney Supply Co.

FDA 510(k) clearance K760965 for BEDSIDE CONSOLES (11-3-910 & 11-3-930), Substantially Equivalent on 1976-12-06. Applicant: Seattle Artificial Kidney Supply Co.. Device class: 2.

Clearance details

Applicant: Seattle Artificial Kidney Supply Co.
Product code: Code FKQ
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1976-11-04
Decision date: 1976-12-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FKQ

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K052764 — DIACAP ULTRA DIALYSIS FLUID FILTER2006-06-09
K893612 — TWO TANK DISSOLUTION MODULE1989-07-24
K874084 — MULTIPLE ARTIFICIAL KIDNEY SYSTEMS (MAKS) #IDM1988-04-27
K873421 — KAWASUMI A.V. FISTULA SET1987-10-09
K870889 — ACID FUCHSIN SOLUTIONS1987-07-08

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.