510(k) K021060
- Device
- FRESENIUS ICARE MONITORING SYSTEM
- Applicant
- FRESENIUS MEDICAL CARE NORTH AMERICA
- 510(k) number
- K021060
- Product code
- FKP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-11-13
- Date received
- 2002-04-02
- Regulation
- 876.5820
- Classification name
- System, Dialysate Delivery, Single Patient
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- NICHOLE RIEK
- Address
- 95 Hayden Ave. Lexington MA US 02420 02420
FDA Registration Numbers#
- 2132111
- 2150060
- 3029754060
Source Documents#
Other 510(k) Records For Product Code FKP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K181991 | NxStage Connected Health System | Nxstage Medical, Inc. | 2018-09-26 |
| K131739 | NXSTAGE CONNECTED HEALTH SYSTEM | Nxstage Medical, Inc. | 2013-10-10 |
| K130460 | NXSTAGE DOSING CALCULATOR | Nxstage Medical, Inc. | 2013-07-11 |
| K040074 | ONEVIEW INTERFACE | Nxstage Medical, Inc. | 2004-04-08 |
| K003615 | STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPS | Environmental Test Systems, Inc. | 2001-02-01 |
| K992255 | CKHEMO, MODEL CKHEMO VERSION 1.0 | Csam, Inc. | 1999-11-30 |
| K964264 | HIGH RANGE PEROXIDE TEST STRIP | Integrated Biomedical Technology, Inc. | 1997-06-16 |
| K955423 | PACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM | Fresenius USA, Inc. | 1996-06-13 |
| K953854 | WATERCHECK REAGENT STRIP FOR CHLORINE & PEROXIDE | Integrated Biomedical Technology, Inc. | 1996-03-11 |
| K930181 | BIOPURE DIALYSATE CONCENTRATE MIX SYST/CONCENTRATE | Fresenius USA, Inc. | 1995-11-29 |
| K922757 | SPS 1550 SINGLE NEEDLE PATIENT SYSTEM | Baxter Healthcare Corp | 1995-02-13 |
| K921456 | FRESENIUS 3008/FDS-08 DIALYSATE DELIVERY SYSTEM | Fresenius USA, Inc. | 1994-04-20 |
| K910215 | DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYST | Cd Medical, Inc. | 1991-04-09 |
| K905793 | COBE CENTRY 2 BICART OPTION KIT | Cobe Laboratories, Inc. | 1991-02-12 |
| K905388 | COBE CENTRYSYSTEM 3 BICART OPTION KIT | Cobe Laboratories, Inc. | 1991-02-11 |
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases