HEMOFILTRATION SYSTEM 10— 510(k) K862716

Substantially Equivalent

Gambro, Inc.

FDA 510(k) clearance K862716 for HEMOFILTRATION SYSTEM 10, Substantially Equivalent on 1986-09-09. Applicant: Gambro, Inc.. Device class: 2.

Clearance details

Applicant: Gambro, Inc.
Product code: Code FII
Device class: Class 2
Regulation: 21 CFR 876.5860
Advisory panel: Gastroenterology, Urology
Date received: 1986-07-17
Decision date: 1986-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lincolnshire, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FII

K030470 — NXSTAGE SYSTEM ONE2003-07-07
K881270 — GAMBRO MULTIPURPOSE SYSTEM MPS-101988-08-24
K872364 — HEMODIALYSIS (SPS), MODEL 550, CODE 5M13091987-10-13
K822386 — COTRAL I W/4.5 L/HR. ULTRAFILTRAT. CAPA1982-10-06

More clearances from Gambro, Inc.

K083158 — EXALIS, SOFTWARE VERSION 1.152009-06-05
K070643 — PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.352007-11-02
K032431 — PRISMA M60/M100 SETS2003-09-15
K896758 — GAMBRO BICARBONATE MONITOR BCM 10-31990-09-28
K896757 — GAMBRO AK-10 DIALYSIS SYSTEM FOR HIGH FLOWS1990-08-30

Data sourced from openFDA. This site is unofficial and independent of the FDA.