510(k) K853346 ยท BZK Spirometer, Monitoring (W/Wo Alarm)
BEAR NICU-1
| Applicant | Bear Medical Systems, Inc., Riverside CA, US |
| Decision | Substantially Equivalent, Sep 11, 1985 |
| Received | Aug 12, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K853346
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.