510(k) K001069 ยท OLW Index-Generating Electroencephalograph Software
MODEL 4000 EEG MONITOR WITH PSI (PSA4000)
| Applicant | Physiometrix, Inc., North Billerica MA, US |
| Decision | Substantially Equivalent, Jun 30, 2000 |
| Received | Apr 3, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001069
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.