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510(k) K871218

Device
MONITRAL S GS HEMODIALYSIS SINGLE PATIENT UNIT
Applicant
HOSPAL MEDICAL CORP.
510(k) number
K871218
Product code
FKP  
Decision
Substantially Equivalent (SESE)
Decision date
1987-04-30
Date received
1987-03-27
Regulation
876.5820
Classification name
System, Dialysate Delivery, Single Patient
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
J. L FRESSINET
Address
21 Northfield Ave. Raritan Center Edison NJ US 08837 08837

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FKP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K181991NxStage Connected Health SystemNxstage Medical, Inc.2018-09-26
K131739NXSTAGE CONNECTED HEALTH SYSTEMNxstage Medical, Inc.2013-10-10
K130460NXSTAGE DOSING CALCULATORNxstage Medical, Inc.2013-07-11
K040074ONEVIEW INTERFACENxstage Medical, Inc.2004-04-08
K021060FRESENIUS ICARE MONITORING SYSTEMFresenius Medical Care North America2002-11-13
K003615STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPSEnvironmental Test Systems, Inc.2001-02-01
K992255CKHEMO, MODEL CKHEMO VERSION 1.0Csam, Inc.1999-11-30
K964264HIGH RANGE PEROXIDE TEST STRIPIntegrated Biomedical Technology, Inc.1997-06-16
K955423PACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAMFresenius USA, Inc.1996-06-13
K953854WATERCHECK REAGENT STRIP FOR CHLORINE & PEROXIDEIntegrated Biomedical Technology, Inc.1996-03-11
K930181BIOPURE DIALYSATE CONCENTRATE MIX SYST/CONCENTRATEFresenius USA, Inc.1995-11-29
K922757SPS 1550 SINGLE NEEDLE PATIENT SYSTEMBaxter Healthcare Corp1995-02-13
K921456FRESENIUS 3008/FDS-08 DIALYSATE DELIVERY SYSTEMFresenius USA, Inc.1994-04-20
K910215DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTCd Medical, Inc.1991-04-09
K905793COBE CENTRY 2 BICART OPTION KITCobe Laboratories, Inc.1991-02-12

Legacy Summary#

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FDA Review#

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