510(k) K193411 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
O2asis Personal Oxygen Humidifier
| Applicant | Perma Pure, LLC, Lakewood NJ, US |
| Decision | Substantially Equivalent, Nov 12, 2020 |
| Received | Dec 9, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193411
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.