510(k) K072845 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
PRECISION FLOW
| Applicant | Vapotherm, Inc., Washington DC, US |
| Decision | Substantially Equivalent, Jul 17, 2008 |
| Received | Oct 4, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K072845
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 25, 2014 | Vapotherm, Inc. Vapotherm Precision Flow, Disposable Patient Circuit
PF-DPC-High. For use with the Precision Flow system
Precision Flow" is intended for use to add warm moisture to breathing gases from an external s Terminated |
BTT | None listed |
| Sep 25, 2014 | Vapotherm, Inc. Vapotherm Precision Flow,Disposable Patient Circuit
PF-E-DPC-High. For use with the Precision Flow system
Precision Flow" is intended for use to add warm moisture to breathing gases from an external Terminated |
BTT | None listed |
| Sep 25, 2014 | Vapotherm, Inc. Vapotherm Precision Flow,Disposable Patient Circuit
PFH-DPC-High. For use with the Heliox Precision Flow system
Precision Flow" is intended for use to add warm moisture to breathing gases from an ext Terminated |
BTT | None listed |
| Sep 25, 2014 | Vapotherm, Inc. Vapotherm Precision Flow,Disposable Patient Circuit
PFNODPC-High.
For use with the Precision Flow system and Ikaria INOmax DSIR
System.
This DPC allows clinicians to administer nitric oxide non-invas Terminated |
BTT | None listed |
| Sep 25, 2014 | Vapotherm, Inc. Vapotherm Precision Flow,Disposable Patient Circuit
PF-DPC-Low.
For use with the Precision Flow system
Precision Flow" is intended for use to add warm moisture to breathing gases from an external sour Terminated |
BTT | None listed |
| Sep 25, 2014 | Vapotherm, Inc. Vapotherm Precision Flow,Disposable Patient Circuit
PF-E-DPC-Low.
PF-DPC-Low packaged with compatible cannulas for evaluation of the
Precision Flow system Terminated |
BTT | None listed |
| Sep 25, 2014 | Vapotherm, Inc. Vapotherm Precision Flow,Disposable Patient Circuit
PFHDPC-Low.
For use with the Heliox Precision Flow system
Precision Flow" is intended for use to add warm moisture to breathing gases from an exter Terminated |
BTT | None listed |
| Sep 25, 2014 | Vapotherm, Inc. Vapotherm Precision Flow,Disposable Patient Circuit
PF-NODPC-Low.
For use with the Precision Flow system and Ikaria INOmax DSIR
System.
This DPC allows clinicians to administer nitric oxide non-inva Terminated |
BTT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.