Physiometrix, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
22
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K051874SEDLINE SEDATION MONITOR WITH FRONTAL PSI AND SEDTRACE EEG ELECTROSE SETSeptember 2, 2005
K033999SEDLINE WITH FRONTAL PSIFebruary 6, 2004
K020670MODEL 4310 PSARRAY2 EEG ELECTRODEOctober 8, 2002
K020671PSA4000 EEG MONITOR WITH FRONTAL PSIOctober 4, 2002
K001069MODEL 4000 EEG MONITOR WITH PSI (PSA4000)June 30, 2000
K001055MODEL 4300 PSARRAY EEG ELECTRODE SETMay 11, 2000
K970942MODEL 1320, NEUROLINK II NEUROMONITORING SYSTEMJune 2, 1997
K970694MODEL 1700, HYDRO PREPMay 14, 1997
K962447EQUINOX DIGITAL EEG SYSTEMDecember 12, 1996
K962157MODEL 1310 NEUROLINK NEUROMONITORING SYSTEMNovember 25, 1996
K961609MODEL 1220, OR E-NET (54-62 CM)May 10, 1996
K960885MODEL 1240, SMALL E NETApril 26, 1996
K960873MODEL 1210, MEDIUM E-NETApril 26, 1996
K960732HYDROSPOT EEG ELECTRODE MODEL 1501, HYDROSPOT LEADWIRE MODEL 1500April 15, 1996
K953449MODEL 1207, HYDRODOT NEUROMONITORING SYSTEM ADHESIVE PADSOctober 12, 1995
K946318MODEL 1001, HYDRODOT(TM) NEUROMONITORING SYSTEM WITH E NET(TM) EEG INTERFACE CABLEApril 24, 1995
K934505TRIGEL MULTIFUNCTION ELECTRODENovember 22, 1994
K940219TRIGEL- MULTIFUNCTION ELECTRODEApril 12, 1994
K935260PHYSIOMETRIX CABLE ADAPTER MODIFICATIONDecember 23, 1993
K930080E*NET NEUROMONITORING SYSTEMOctober 19, 1993