Company ยท US
Physiometrix, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1992 to 2005. Name variants (Inc, Corp, punctuation) are merged.
22510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 2, 2005 | K051874 | SEDLINE SEDATION MONITOR WITH FRONTAL PSI AND SEDTRACE EEG ELECTROSE SET Physiometrix, Inc. | OLW |
| Feb 6, 2004 | K033999 | SEDLINE WITH FRONTAL PSI Physiometrix, Inc. | OLW |
| Oct 8, 2002 | K020670 | MODEL 4310 PSARRAY2 EEG ELECTRODE Physiometrix, Inc. | GXY |
| Oct 4, 2002 | K020671 | PSA4000 EEG MONITOR WITH FRONTAL PSI Physiometrix, Inc. | OLW |
| Jun 30, 2000 | K001069 | MODEL 4000 EEG MONITOR WITH PSI (PSA4000) Physiometrix, Inc. | OLW |
| May 11, 2000 | K001055 | MODEL 4300 PSARRAY EEG ELECTRODE SET Physiometrix, Inc. | GXY |
| Jun 2, 1997 | K970942 | MODEL 1320, NEUROLINK II NEUROMONITORING SYSTEM Physiometrix, Inc. | GWQ |
| May 14, 1997 | K970694 | MODEL 1700, HYDRO PREP Physiometrix, Inc. | GYB |
| Dec 12, 1996 | K962447 | EQUINOX DIGITAL EEG SYSTEM Physiometrix, Inc. | GWQ |
| Nov 25, 1996 | K962157 | MODEL 1310 NEUROLINK NEUROMONITORING SYSTEM Physiometrix, Inc. | GWQ |
| May 10, 1996 | K961609 | MODEL 1220, OR E-NET (54-62 CM) Physiometrix, Inc. | GXY |
| Apr 26, 1996 | K960885 | MODEL 1240, SMALL E NET Physiometrix, Inc. | GXY |
| Apr 26, 1996 | K960873 | MODEL 1210, MEDIUM E-NET Physiometrix, Inc. | GXY |
| Apr 15, 1996 | K960732 | HYDROSPOT EEG ELECTRODE MODEL 1501, HYDROSPOT LEADWIRE MODEL 1500 Physiometrix, Inc. | GXY |
| Oct 12, 1995 | K953449 | MODEL 1207, HYDRODOT NEUROMONITORING SYSTEM ADHESIVE PADS Physiometrix, Inc. | GWQ |
| Apr 24, 1995 | K946318 | MODEL 1001, HYDRODOT(TM) NEUROMONITORING SYSTEM WITH E NET(TM) EEG INTERFACE CABLE Physiometrix, Inc. | GXY |
| Nov 22, 1994 | K934505 | TRIGEL MULTIFUNCTION ELECTRODE Physiometrix, Inc. | DRX |
| Apr 12, 1994 | K940219 | TRIGEL- MULTIFUNCTION ELECTRODE Physiometrix, Inc. | GEI |
| Dec 23, 1993 | K935260 | PHYSIOMETRIX CABLE ADAPTER MODIFICATION Physiometrix, Inc. | IKD |
| Oct 19, 1993 | K930080 | E*NET NEUROMONITORING SYSTEM Physiometrix, Inc. | GWQ |
| Sep 9, 1993 | K931885 | DRIGEL MULTIFUNCTION ELECTRODE Physiometrix, Inc. | GEI |
| Oct 13, 1992 | K921207 | DRIGEL DEFIBRILLATOR/SYNCHRONIZED COARDIOVERSION Physiometrix, Inc. | DRX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||