Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Physiometrix with 22 510(k) clearances. The most recent is a 510(k) clearance dated Sep 2, 2005: SEDLINE SEDATION MONITOR WITH FRONTAL PSI AND SEDTRACE EEG ELECTROSE SET.
| Date | Record | Source |
|---|---|---|
| Sep 2, 2005 | SEDLINE SEDATION MONITOR WITH FRONTAL PSI AND SEDTRACE EEG ELECTROSE SETK051874 · OLW | 510(k) clearances |
| Feb 6, 2004 | SEDLINE WITH FRONTAL PSIK033999 · OLW | 510(k) clearances |
| Oct 8, 2002 | MODEL 4310 PSARRAY2 EEG ELECTRODEK020670 · GXY | 510(k) clearances |
| Oct 4, 2002 | PSA4000 EEG MONITOR WITH FRONTAL PSIK020671 · OLW | 510(k) clearances |
| Jun 30, 2000 | MODEL 4000 EEG MONITOR WITH PSI (PSA4000)K001069 · OLW | 510(k) clearances |
| May 11, 2000 | MODEL 4300 PSARRAY EEG ELECTRODE SETK001055 · GXY | 510(k) clearances |
| Jun 2, 1997 | MODEL 1320, NEUROLINK II NEUROMONITORING SYSTEMK970942 · GWQ | 510(k) clearances |
| May 14, 1997 | MODEL 1700, HYDRO PREPK970694 · GYB | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
