510(k) K082351 ยท CBK Ventilator, Continuous, Facility Use
NEPTUNE HYPERBARIC VENTILATOR
| Applicant | Level-5, Inc., Washington DC, US |
| Decision | Substantially Equivalent, Jan 2, 2009 |
| Received | Aug 15, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082351
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.