Medical Device Manufacturer · US , Sunnyvale , CA

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

22 submissions · 22 cleared · Since 1992

Total

Cleared

Denied

Physiometrix, Inc. has 22 FDA 510(k) cleared neurology devices. Based in Sunnyvale, US.

Historical record: 22 cleared submissions from 1992 to 2005.

Browse the complete list of FDA 510(k) cleared neurology devices from this manufacturer. Filter by specialty or product code using the sidebar.

Physiometrix, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

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

22 devices

1-22 of 22

Cleared Sep 02, 2005

SEDLINE SEDATION MONITOR WITH FRONTAL PSI AND SEDTRACE EEG ELECTROSE SET

K051874 · OLW

Neurology · 53d

Cleared Feb 06, 2004

SEDLINE WITH FRONTAL PSI

K033999 · OLW

Neurology · 44d

Cleared Oct 08, 2002

MODEL 4310 PSARRAY2 EEG ELECTRODE

K020670 · GXY

Neurology · 221d

Cleared Oct 04, 2002

PSA4000 EEG MONITOR WITH FRONTAL PSI

K020671 · OLW

Neurology · 217d

Cleared Jun 30, 2000

MODEL 4000 EEG MONITOR WITH PSI (PSA4000)

K001069 · OLW

Neurology · 88d

Cleared May 11, 2000

MODEL 4300 PSARRAY EEG ELECTRODE SET

K001055 · GXY

Neurology · 38d

Cleared Jun 02, 1997

MODEL 1320, NEUROLINK II NEUROMONITORING SYSTEM

K970942 · GWQ

Neurology · 80d

Cleared May 14, 1997

MODEL 1700, HYDRO PREP

K970694 · GYB

Neurology · 78d

Cleared Dec 12, 1996

EQUINOX DIGITAL EEG SYSTEM

K962447 · GWQ

Neurology · 171d

Cleared Nov 25, 1996

MODEL 1310 NEUROLINK NEUROMONITORING SYSTEM

K962157 · GWQ

Neurology · 174d

Cleared May 10, 1996

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

K961609 · GXY

Neurology · 15d

Cleared Apr 26, 1996

MODEL 1210, MEDIUM E-NET

K960873 · GXY

Neurology · 53d

Cleared Apr 26, 1996

MODEL 1240, SMALL E NET

K960885 · GXY

Neurology · 53d

Cleared Apr 15, 1996

HYDROSPOT EEG ELECTRODE MODEL 1501, HYDROSPOT LEADWIRE MODEL 1500

K960732 · GXY

Neurology · 53d

Cleared Oct 12, 1995

MODEL 1207, HYDRODOT NEUROMONITORING SYSTEM ADHESIVE PADS

K953449 · GWQ

Neurology · 86d

Cleared Apr 24, 1995

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

K946318 · GXY

Neurology · 117d

Cleared Nov 22, 1994

TRIGEL MULTIFUNCTION ELECTRODE

K934505 · DRX

Cardiovascular · 433d

Cleared Apr 12, 1994

TRIGEL- MULTIFUNCTION ELECTRODE

K940219 · GEI

General & Plastic Surgery · 84d

Cleared Dec 23, 1993

PHYSIOMETRIX CABLE ADAPTER MODIFICATION

K935260 · IKD

Physical Medicine · 51d

Cleared Oct 19, 1993

E*NET NEUROMONITORING SYSTEM

K930080 · GWQ

Neurology · 285d

Cleared Sep 09, 1993

DRIGEL MULTIFUNCTION ELECTRODE

K931885 · GEI

General & Plastic Surgery · 147d

Cleared Oct 13, 1992

DRIGEL DEFIBRILLATOR/SYNCHRONIZED COARDIOVERSION

K921207 · DRX

Cardiovascular · 215d

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

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

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