510(k) K111640 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
PRECISION FLOW(R) - HELIOX
| Applicant | Vapotherm, Inc., Stevensville MD, US |
| Decision | Substantially Equivalent, Oct 7, 2011 |
| Received | Jun 13, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111640
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 17, 2023 | Vapotherm Low Flow Disposable Patient Circuit for the Precision Flow System, Product Code PF-DPC-LOW Open, Classified |
BTT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.