510(k) K092481 ยท FIP Subsystem, Water Purification
HEMODIALYSIS CARBON EXCHANGE, DUAL BED DEIONIZER EXCHANGE, MIXED BED DEIONIZER EXCHANGE, MODEL .60MAW,1.2MAW,3.6MAW, 1.2
| Applicant | New Aqua, LLC (Dba Aqua Systems), Avon IN, US |
| Decision | Substantially Equivalent, Apr 2, 2010 |
| Received | Aug 13, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092481
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.