510(k) K112728 ยท FRF Cleaner, Air, Medical Recirculating
HEPAIRX VENTILATING AIR PURIFIER
| Applicant | Air Innovations, Inc., North Syracuse NY, US |
| Decision | Substantially Equivalent, Jan 23, 2013 |
| Received | Sep 20, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112728
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.