Medical Device Manufacturer · US , Sunnyvale , CA

Physiometrix, Inc. - FDA 510(k) Cleared Devices

22 submissions · 22 cleared · Since 1992

22

Total

22

Cleared

0

Denied

FDA 510(k) Regulatory Record - Physiometrix, Inc. Neurology ✕

17 devices

1-17 of 17

Cleared Sep 02, 2005

SEDLINE SEDATION MONITOR WITH FRONTAL PSI AND SEDTRACE EEG ELECTROSE SET

Neurology · 53d

Cleared Feb 06, 2004

SEDLINE WITH FRONTAL PSI

Neurology · 44d

Cleared Oct 08, 2002

MODEL 4310 PSARRAY2 EEG ELECTRODE

Neurology · 221d

Cleared Oct 04, 2002

PSA4000 EEG MONITOR WITH FRONTAL PSI

Neurology · 217d

Cleared Jun 30, 2000

MODEL 4000 EEG MONITOR WITH PSI (PSA4000)

Neurology · 88d

Cleared May 11, 2000

MODEL 4300 PSARRAY EEG ELECTRODE SET

Neurology · 38d

Cleared Jun 02, 1997

MODEL 1320, NEUROLINK II NEUROMONITORING SYSTEM

Neurology · 80d

Cleared May 14, 1997

MODEL 1700, HYDRO PREP

Neurology · 78d

Cleared Dec 12, 1996

EQUINOX DIGITAL EEG SYSTEM

Neurology · 171d

Cleared Nov 25, 1996

MODEL 1310 NEUROLINK NEUROMONITORING SYSTEM

Neurology · 174d

Cleared May 10, 1996

MODEL 1220, OR E-NET (54-62 CM)

Neurology · 15d

Cleared Apr 26, 1996

MODEL 1210, MEDIUM E-NET

Neurology · 53d

Cleared Apr 26, 1996

MODEL 1240, SMALL E NET

Neurology · 53d

Cleared Apr 15, 1996

HYDROSPOT EEG ELECTRODE MODEL 1501, HYDROSPOT LEADWIRE MODEL 1500

Neurology · 53d

Cleared Oct 12, 1995

MODEL 1207, HYDRODOT NEUROMONITORING SYSTEM ADHESIVE PADS

Neurology · 86d

Cleared Apr 24, 1995

MODEL 1001, HYDRODOT(TM) NEUROMONITORING SYSTEM WITH E NET(TM) EEG INTERFACE...

Neurology · 117d

Cleared Oct 19, 1993

E*NET NEUROMONITORING SYSTEM

Neurology · 285d