510(k) K042018 ยท FIP Subsystem, Water Purification
ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI SYSTEM, BACK-UP PEDI SYSTEM
| Applicant | Simply Clean Air & Water, Inc., Newington CT, US |
| Decision | Substantially Equivalent, Apr 15, 2005 |
| Received | Jul 27, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042018
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.