510(k) K212938 ยท BZG Spirometer, Diagnostic
Vitalograph Model 6000 Alpha
| Applicant | Vitalograph Ireland, Ltd., Ennis Co Clare, IE |
| Decision | Substantially Equivalent, Jan 26, 2022 |
| Received | Sep 15, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212938
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.