# Physiometrix, Inc.

- Location (FDA's records): North Billerica, MA
- FDA decisions: 22 (1992–2005): 22 510(k) clearances
- Product codes: GXY (7), GWQ (5), OLW (4), DRX (2), GEI (2), IKD (1), GYB (1)
- Predicates its devices cite: 12 (11 its own); citations of its devices by later devices: 15 (11 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Neuroconcepts, Inc.: 1 (https://510kreport.com/company/neuroconcepts)

## Firms that cite its devices most
- Masimo Corporation: 1 (https://510kreport.com/company/masimo)
- Wuhan Greentek Pty, Ltd.: 1 (https://510kreport.com/company/wuhan-greentek)
- Brainz Instruments, Ltd.: 1 (https://510kreport.com/company/brainz-instruments)
- Neuronetrix Solutions: 1 (https://510kreport.com/company/neuronetrix-solutions)

## Its most-cited devices
- K930080: E*Net Neuromonitoring System (1993), cited by 6
- K020670: Model 4310 PSARRAY2 Eeg Electrode (2002), cited by 1
- K962447: Equinox Digital Eeg System (1996), cited by 1
- K033999: Sedline with Frontal Psi (2004), cited by 1
- K970694: Model 1700, Hydro Prep (1997), cited by 1
- K960732: Hydrospot Eeg Electrode Model 1501, Hydrospot Leadwire Model 1500 (1996), cited by 1

## Recent decisions
- K051874: Sedline Sedation Monitor with Frontal Psi and Sedtrace Eeg Electrose Set (Sep 2, 2005)
- K033999: Sedline with Frontal Psi (Feb 6, 2004)
- K020670: Model 4310 PSARRAY2 Eeg Electrode (Oct 8, 2002)
- K020671: PSA4000 Eeg Monitor with Frontal Psi (Oct 4, 2002)
- K001069: Model 4000 Eeg Monitor with Psi (PSA4000) (Jun 30, 2000)
- K001055: Model 4300 Psarray Eeg Electrode Set (May 11, 2000)
- K970942: Model 1320, Neurolink II Neuromonitoring System (Jun 2, 1997)
- K970694: Model 1700, Hydro Prep (May 14, 1997)

Source page: https://510kreport.com/company/physiometrix