Cleared Traditional

FRESENIUS BLOOD TEMPERATURE MONITOR

K941460 · Fresenius USA, Inc. · Gastroenterology & Urology
Jul 1996
Decision
831d
Days
Class 2
Risk

About This 510(k) Submission

K941460 is an FDA 510(k) clearance for the FRESENIUS BLOOD TEMPERATURE MONITOR, a System, Hemodialysis, Access Recirculation Monitoring (Class II — Special Controls, product code MQS), submitted by Fresenius USA, Inc. (Walnut Creek, US). The FDA issued a Cleared decision on July 3, 1996, 831 days after receiving the submission on March 25, 1994. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.

Submission Details

510(k) Number K941460 FDA.gov
FDA Decision Cleared SESE
Date Received March 25, 1994
Decision Date July 03, 1996
Days to Decision 831 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement

Device Classification

Product Code MQS — System, Hemodialysis, Access Recirculation Monitoring
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5820

More from Fresenius USA, Inc.

View all
FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODIFIED F400 LOW VOL HEMOCONCENTRATOR W/TUBING SET F3000TS
K992275 · KDI · Aug 1999
FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX
K970700 · MSE · Sep 1998
FRESENIUS F SERIES HEMOCONCENTRATORS F400,F500,F700,F800,F400TS,F500TS,F700S,F800TS
K974584 · KDI · May 1998
C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM MODEL 900500 1, AT1 AUTOTRANSFUSION SET MODEL 900 510 1, PSQ SET (DD) MODEL 61
K973378 · CAC · Nov 1997
2008H ON LINE CLEARANCE MONITOR
K961465 · KDI · Jul 1997