510(k) K080117 ยท LGM Chamber, Patient Isolation
PATIENT ISOLATION UNIT, MODEL G019-1000
| Applicant | Gentex Corporation, Rancho Cucamonga CA, US |
| Decision | Substantially Equivalent, Jan 30, 2009 |
| Received | Jan 17, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080117
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.