FDA 510(k) Applications Submitted by DAWN E FRAZER
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K960732 |
02/22/1996 |
HYDROSPOT EEG ELECTRODE MODEL 1501, HYDROSPOT LEADWIRE MODEL 1500 |
PHYSIOMETRIX, INC. |
K970694 |
02/25/1997 |
MODEL 1700, HYDRO PREP |
PHYSIOMETRIX, INC. |
K020670 |
03/01/2002 |
MODEL 4310 PSARRAY2 EEG ELECTRODE |
PHYSIOMETRIX, INC. |
K020671 |
03/01/2002 |
PSA4000 EEG MONITOR WITH FRONTAL PSI |
PHYSIOMETRIX, INC. |
K960873 |
03/04/1996 |
MODEL 1210, MEDIUM E-NET |
PHYSIOMETRIX, INC. |
K960885 |
03/04/1996 |
MODEL 1240, SMALL E NET |
PHYSIOMETRIX, INC. |
K970942 |
03/14/1997 |
MODEL 1320, NEUROLINK II NEUROMONITORING SYSTEM |
PHYSIOMETRIX, INC. |
K001055 |
04/03/2000 |
MODEL 4300 PSARRAY EEG ELECTRODE SET |
PHYSIOMETRIX, INC. |
K001069 |
04/03/2000 |
MODEL 4000 EEG MONITOR WITH PSI (PSA4000) |
PHYSIOMETRIX, INC. |
K961609 |
04/25/1996 |
MODEL 1220, OR E-NET (54-62 CM) |
PHYSIOMETRIX, INC. |
K962157 |
06/04/1996 |
MODEL 1310 NEUROLINK NEUROMONITORING SYSTEM |
PHYSIOMETRIX, INC. |
K962447 |
06/24/1996 |
EQUINOX DIGITAL EEG SYSTEM |
PHYSIOMETRIX, INC. |
K051874 |
07/11/2005 |
SEDLINE SEDATION MONITOR WITH FRONTAL PSI AND SEDTRACE EEG ELECTROSE SET |
PHYSIOMETRIX, INC. |
K033999 |
12/24/2003 |
SEDLINE WITH FRONTAL PSI |
PHYSIOMETRIX, INC. |
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