510(k) K812046 ยท BZK Spirometer, Monitoring (W/Wo Alarm)
TIDAL VOLUME MONITOR 150
| Applicant | Medix Medical Electronics (U.S.A.), Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Aug 7, 1981 |
| Received | Jul 21, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K812046
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.