510(k) K011397 ยท OMB Automatic Event Detection Software For Full-Montage Electroencephalograph
PERSYST REVEAL
| Applicant | Persyst Development Corp., Prescott AZ, US |
| Decision | Substantially Equivalent, Aug 3, 2001 |
| Received | May 7, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011397
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.