510(k) K111740 ยท FIP Subsystem, Water Purification
AMERIWATER MRO PORTABLE REVERSE OSMOSIS SYSTEM - SINGLE PATIENT, 1 TO 3 STATION
| Applicant | Ameriwater, Dayton OH, US |
| Decision | Substantially Equivalent, Oct 5, 2011 |
| Received | Jun 21, 2011 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K111740
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 6, 2012 | AmeriWater Inc AmeriWater MRO Dialysis RO+ System, AmeriWater 1303 Stanley Avenue, Dayton, OH 45404 (800) 535-5585 www.AMERIWATER.com.
The AmeriWater MRO Portable Reverse Osmosis Systems are water treatment systems Terminated |
FIP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.