510(k) K110578 ยท FIP Subsystem, Water Purification
MILLENIUM HX PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEM
| Applicant | Mar Cor Purification, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, May 20, 2011 |
| Received | Mar 1, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110578
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 14, 2014 | Mar Cor Purification Mar Cor Purification Millenium HX Portable Reverse Osmosis System. Model 3025975.
Product Usage: Water Purification System is intended to be used as a dialysis accessory to produce water throug Terminated |
FIP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.