FDA 510(k) Applications for Medical Device Product Code "FKP"
(System, Dialysate Delivery, Single Patient)
FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K992255 |
CSAM, INC. |
CKHEMO, MODEL CKHEMO VERSION 1.0 |
11/30/1999 |
K003615 |
ENVIRONMENTAL TEST SYSTEMS, INC. |
STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPS |
02/01/2001 |
K021060 |
FRESENIUS MEDICAL CARE NORTH AMERICA |
FRESENIUS ICARE MONITORING SYSTEM |
11/13/2002 |
K955423 |
FRESENIUS USA, INC. |
PACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM |
06/13/1996 |
K964264 |
INTEGRATED BIOMEDICAL TECHNOLOGY, INC. |
HIGH RANGE PEROXIDE TEST STRIP |
06/16/1997 |
K953854 |
INTEGRATED BIOMEDICAL TECHNOLOGY, INC. |
WATERCHECK REAGENT STRIP FOR CHLORINE & PEROXIDE |
03/11/1996 |
K181991 |
NxStage Medical, Inc |
NxStage Connected Health System |
09/26/2018 |
K131739 |
NXSTAGE MEDICAL, INC. |
NXSTAGE CONNECTED HEALTH SYSTEM |
10/10/2013 |
K130460 |
NXSTAGE MEDICAL, INC. |
NXSTAGE DOSING CALCULATOR |
07/11/2013 |
K040074 |
NXSTAGE MEDICAL, INC. |
ONEVIEW INTERFACE |
04/08/2004 |
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