510(k) K163223 ยท LGM Chamber, Patient Isolation
ORCA (tm) - Operational Rescue Containment Apparatus
| Applicant | Isovac Products, LLC, Romeoville IL, US |
| Decision | Substantially Equivalent, Nov 2, 2017 |
| Received | Nov 16, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163223
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.