510(k) K060296
- Device
- NXSTAGE DIALYSATE PREPARATION MODULE
- Applicant
- NXSTAGE MEDICAL, INC.
- 510(k) number
- K060296
- Product code
- FKR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-03-31
- Date received
- 2006-02-06
- Regulation
- 876.5820
- Classification name
- Subsystem, Proportioning
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- NORMA LEMAY
- Address
- 439 S. Union St. Suite 501 Lawrence MA US 01843 01843
FDA Registration Numbers#
- 3003464075
- 9616074
- 1649518
Source Documents#
Other 510(k) Records For Product Code FKR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K140571 | NXSTAGE PUREFLOW SL | Nxstage Medical, Inc. | 2014-05-15 |
| K111174 | NXSTAGE PUREFLOW SL | Nxstage Medical, Inc. | 2011-09-19 |
| K080919 | NXSTAGE PUREFLOW SL | Nxstage Medical, Inc. | 2008-10-15 |
| K043436 | NXSTAGE DIALYSATE PREPARATION MODULE, MODEL NX0269 | Nxstage Medical, Inc. | 2005-03-17 |
| K850435 | SARTORIUS AQUASART SM 40035 - DIALYSATE SYS | Sartorius Filters, Inc. | 1985-06-04 |
| K850756 | AUTO-D AUTOMATIC DISINFECTION ACCESS/ATTACHMENTS | Travenol Laboratories, S.A. | 1985-03-20 |
| K810605 | CHEMATIC BICARBONATE DIALYSATE SYSTEM | Trimedyne, Inc. | 1981-06-16 |
| K810127 | GAMBRO BICARBONATE MODULE, BCM-10 | Gambro, Inc. | 1981-02-25 |
| K802465 | BICARB-O-MATE HEMODIALYSIS SOD. BICARB. | Renal Systems, Inc. | 1980-11-12 |
| K800772 | MOD. DM-357 BICARBONATE RETROFIT KIT | Extracorporeal Medical Specialities, Inc. | 1980-05-14 |
| K781303 | BIO-PRO UNIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-10-02 |
Legacy Summary#
summary
FDA Review#
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