510(k) K161295 · BZC Calculator, Pulmonary Function Data
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| Applicant | Pulmone Advanced Medical Devices, Ltd., RaAnanna, IL |
| Decision | Substantially Equivalent, Oct 21, 2016 |
| Received | May 9, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161295
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.