510(k) K200948 ยท QDA Electrocardiograph Software For Over-The-Counter Use
Fitbit ECG App
| Applicant | Fitbit, Inc., San Francisco CA, US |
| Decision | Substantially Equivalent, Sep 11, 2020 |
| Received | Apr 8, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200948
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.