Physiometrix, Inc.
North Billerica, MA, US
Physiometrix, Inc. appears in FDA device records in North Billerica, MA. FDA records list 22 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 22
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 22 510(k) clearances for Physiometrix, Inc. between 1992 and 2005. The busiest year on record is 1996, with 6. The most recent is 2005, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1992 | 1 |
| 1993 | 3 |
| 1994 | 2 |
| 1995 | 2 |
| 1996 | 6 |
| 1997 | 2 |
| 2000 | 2 |
| 2002 | 2 |
| 2004 | 1 |
| 2005 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K051874 | SEDLINE SEDATION MONITOR WITH FRONTAL PSI AND SEDTRACE EEG ELECTROSE SET | OLW | Substantially Equivalent | |
| K033999 | SEDLINE WITH FRONTAL PSI | OLW | Substantially Equivalent | |
| K020670 | MODEL 4310 PSARRAY2 EEG ELECTRODE | GXY | Substantially Equivalent | |
| K020671 | PSA4000 EEG MONITOR WITH FRONTAL PSI | OLW | Substantially Equivalent | |
| K001069 | MODEL 4000 EEG MONITOR WITH PSI (PSA4000) | OLW | Substantially Equivalent | |
| K001055 | MODEL 4300 PSARRAY EEG ELECTRODE SET | GXY | Substantially Equivalent | |
| K970942 | MODEL 1320, NEUROLINK II NEUROMONITORING SYSTEM | GWQ | Substantially Equivalent | |
| K970694 | MODEL 1700, HYDRO PREP | GYB | Substantially Equivalent | |
| K962447 | EQUINOX DIGITAL EEG SYSTEM | GWQ | Substantially Equivalent | |
| K962157 | MODEL 1310 NEUROLINK NEUROMONITORING SYSTEM | GWQ | Substantially Equivalent | |
| K961609 | MODEL 1220, OR E-NET (54-62 CM) | GXY | Substantially Equivalent | |
| K960885 | MODEL 1240, SMALL E NET | GXY | Substantially Equivalent | |
| K960873 | MODEL 1210, MEDIUM E-NET | GXY | Substantially Equivalent | |
| K960732 | HYDROSPOT EEG ELECTRODE MODEL 1501, HYDROSPOT LEADWIRE MODEL 1500 | GXY | Substantially Equivalent | |
| K953449 | MODEL 1207, HYDRODOT NEUROMONITORING SYSTEM ADHESIVE PADS | GWQ | Substantially Equivalent | |
| K946318 | MODEL 1001, HYDRODOT(TM) NEUROMONITORING SYSTEM WITH E NET(TM) EEG INTERFACE CABLE | GXY | Substantially Equivalent | |
| K934505 | TRIGEL MULTIFUNCTION ELECTRODE | DRX | Substantially Equivalent | |
| K940219 | TRIGEL- MULTIFUNCTION ELECTRODE | GEI | Substantially Equivalent | |
| K935260 | PHYSIOMETRIX CABLE ADAPTER MODIFICATION | IKD | Substantially Equivalent | |
| K930080 | E*NET NEUROMONITORING SYSTEM | GWQ | Substantially Equivalent | |
| K931885 | DRIGEL MULTIFUNCTION ELECTRODE | GEI | Substantially Equivalent | |
| K921207 | DRIGEL DEFIBRILLATOR/SYNCHRONIZED COARDIOVERSION | DRX | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain