510(k) K051874 ยท OLW Index-Generating Electroencephalograph Software
SEDLINE SEDATION MONITOR WITH FRONTAL PSI AND SEDTRACE EEG ELECTROSE SET
| Applicant | Physiometrix, Inc., North Billerica MA, US |
| Decision | Substantially Equivalent, Sep 2, 2005 |
| Received | Jul 11, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K051874
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.