510(k) K213754 ยท BZG Spirometer, Diagnostic
SpiroHome Personal, SpiroHome Clinic
| Applicant | Inofab Saglik Teknolojileri A.S, Cankaya, Ankara, TR |
| Decision | Substantially Equivalent, Jun 12, 2023 |
| Received | Nov 30, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213754
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.