510(k) K012549 ยท FRF Cleaner, Air, Medical Recirculating
ADVANCED AIR PURIFICATION SYSTEM; HEPA AIR CLEANING SYSTEM
| Applicant | Healthway Products, Inc., Syracuse NY, US |
| Decision | Substantially Equivalent, Feb 4, 2002 |
| Received | Aug 7, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012549
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 31, 2012 | Healthway Home Products, Inc. Product is a 15x16x27" (WxDxH) air purifier device with one of two different brands next to the control panel: HealthWay or CleanStation. HealthWay brand is sold under model number Deluxe 20600-3 Air Terminated |
FRF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.