510(k) K080922 ยท BZQ Monitor, Breathing Frequency
SALTER LABS ORAL/NASAL THERMAL AIRFLOW SENSOR
| Applicant | Salter Labs, Division of Regulatory Affairs, Arvin CA, US |
| Decision | Substantially Equivalent, Jul 25, 2008 |
| Received | Apr 1, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080922
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 3, 2011 | Salter Laboratories, Division of Regulatory Affairs ThermiSense model 5700-A5
The ThermiSense Model 5700-A5 is a nasal cannula that detects thermal variation during breathing cycles and transmits those variations to a remote Alice-5 Polysomnograph via Terminated |
BZQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.