510(k) K191301 ยท OMB Automatic Event Detection Software For Full-Montage Electroencephalograph
Ceribell Pocket EEG Device
| Applicant | Ceribell, Inc., Mountainview CA, US |
| Decision | Substantially Equivalent, Sep 11, 2019 |
| Received | May 14, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191301
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.