510(k) K931542 ยท BZK Spirometer, Monitoring (W/Wo Alarm)
NEWPORT COMPASS EXHALED TIDAL VOLUME MONITOR
| Applicant | Newport Medical Instruments, Inc., Newport Beach CA, US |
| Decision | Substantially Equivalent, Oct 25, 1993 |
| Received | Mar 29, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K931542
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.