510(k) K053486 ยท BZD Ventilator, Non-Continuous (Respirator)
TREND 200 CPAP DEVICE, MODEL 5CP201; TRENDSET PC SOFTWARE, MODEL TRENDSET
| Applicant | Hoffrichter GmbH, Egale WI, US |
| Decision | Substantially Equivalent, Jan 4, 2006 |
| Received | Dec 15, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K053486
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.