510(k) K974899 ยท FIP Subsystem, Water Purification
GAMBRO CENTRAL WATER TREATMENT SYSTEM CWP 100 - WRO H
| Applicant | Gambro Healthcare, Lakewood CO, US |
| Decision | Substantially Equivalent, Sep 23, 1998 |
| Received | Dec 30, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974899
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 6, 2014 | Mar Cor Purification Mar Cor Purification, Central Water Platform (CWP), 102, 104 and 106.
Product Usage:
The CWP is a Central reverse osmosis system with the intended use of producing water for dialysis of multiple pa Terminated |
FIP | None listed |
| Mar 13, 2014 | Mar Cor Purification Mar Cor Purification CWP Reverse Osmosis System. Models 101, 102, 104, and 106. Terminated |
FIP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.