510(k) K921717 ยท BZK Spirometer, Monitoring (W/Wo Alarm)
BICORE SMARTVALVE OCCLUSION VALVE
| Applicant | Bicore Monitoring Systems, Irvine CA, US |
| Decision | Substantially Equivalent, Nov 6, 1992 |
| Received | Apr 9, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K921717
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.