510(k) K260226 ยท BZK Spirometer, Monitoring (W/Wo Alarm)
ElintMAX Respiratory Monitor (ElintMAX Monitor A1)
| Applicant | Amptron Medical, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Sep 16, 2026 |
| Received | Jan 26, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260226
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.