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Physiometrix, Inc.

FDA 510(k) & PMA Approved Devices — 22 products

Total Devices22
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K051874 SEDLINE SEDATION MONITOR WITH FRONTAL PSI AND SEDTRACE EEG ELECTROSE SETOLW2005-09-02 View
510(k) K033999 SEDLINE WITH FRONTAL PSIOLW2004-02-06 View
510(k) K020670 MODEL 4310 PSARRAY2 EEG ELECTRODEGXY2002-10-08 View
510(k) K020671 PSA4000 EEG MONITOR WITH FRONTAL PSIOLW2002-10-04 View
510(k) K001069 MODEL 4000 EEG MONITOR WITH PSI (PSA4000)OLW2000-06-30 View
510(k) K001055 MODEL 4300 PSARRAY EEG ELECTRODE SETGXY2000-05-11 View
510(k) K970942 MODEL 1320, NEUROLINK II NEUROMONITORING SYSTEMGWQ1997-06-02 View
510(k) K970694 MODEL 1700, HYDRO PREPGYB1997-05-14 View
510(k) K962447 EQUINOX DIGITAL EEG SYSTEMGWQ1996-12-12 View
510(k) K962157 MODEL 1310 NEUROLINK NEUROMONITORING SYSTEMGWQ1996-11-25 View
510(k) K961609 MODEL 1220, OR E-NET (54-62 CM)GXY1996-05-10 View
510(k) K960885 MODEL 1240, SMALL E NETGXY1996-04-26 View
510(k) K960873 MODEL 1210, MEDIUM E-NETGXY1996-04-26 View
510(k) K960732 HYDROSPOT EEG ELECTRODE MODEL 1501, HYDROSPOT LEADWIRE MODEL 1500GXY1996-04-15 View
510(k) K953449 MODEL 1207, HYDRODOT NEUROMONITORING SYSTEM ADHESIVE PADSGWQ1995-10-12 View
510(k) K946318 MODEL 1001, HYDRODOT(TM) NEUROMONITORING SYSTEM WITH E NET(TM) EEG INTERFACE CABLEGXY1995-04-24 View
510(k) K934505 TRIGEL MULTIFUNCTION ELECTRODEDRX1994-11-22 View
510(k) K940219 TRIGEL- MULTIFUNCTION ELECTRODEGEI1994-04-12 View
510(k) K935260 PHYSIOMETRIX CABLE ADAPTER MODIFICATIONIKD1993-12-23 View
510(k) K930080 E*NET NEUROMONITORING SYSTEMGWQ1993-10-19 View
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