510(k) K082657 ยท BYT Ventilator, External Body, Negative Pressure, Adult (Cuirass)
RTX RESPIRATOR
| Applicant | Medivent Limited, London, England, GB |
| Decision | Substantially Equivalent, Oct 8, 2008 |
| Received | Sep 12, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082657
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.