AK-10— 510(k) K771227

Substantially Equivalent

Gambro, Inc.

FDA 510(k) clearance K771227 for AK-10, Substantially Equivalent on 1977-08-02. Applicant: Gambro, Inc.. Device class: 2.

Clearance details

Applicant: Gambro, Inc.
Product code: Code FIL
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1977-07-07
Decision date: 1977-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FIL

K011741 — CRIT-LINE MONITOR III TQA (CLM TQA)2002-07-23
K901038 — SPS 550-IPS (INTEGRATED PATIENT STATION)1990-04-19
K890329 — FRESENIUS 2008 BSS BEDSIDE DIALYSIS SYSTEM1989-05-11
K790824 — REPGREEN ULTRAFILTRATION MONITOR1979-06-27
K781633 — ULTRAFILTRATION SCALE1978-12-07

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.