510(k) K163109 ยท CBF Chamber, Hyperbaric
OxyHeal 4000 Multiplace Hyperbaric Chamber Family
| Applicant | Oxyheal Medical Systems, Inc., National City CA, US |
| Decision | Substantially Equivalent, Mar 22, 2017 |
| Received | Nov 7, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K163109
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.