510(k) K211305 ยท DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
ANNE One
| Applicant | Sibel, Inc., Niles IL, US |
| Decision | Substantially Equivalent, Sep 14, 2021 |
| Received | Apr 29, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211305
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.