Equinox Digital EEG System
FDA 510(k) K962447 · Physiometrix, Inc.
510(k) numberK962447
Submission
- Device name
- Equinox Digital EEG System
- Applicant
- Physiometrix, Inc.
North Billerica, MA, US - Received
- June 24, 1996
- Decision date
- December 12, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GWQ – Full-Montage Standard Electroencephalograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.1400
- Specialty
- Neurology
Acquire, display, store, and archive electroencephalographic signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations
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More from iMediSync, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K051874 | Sedline Sedation Monitor with Frontal Psi and Sedtrace EEG Electrose SetOLW · Special | 09/02/2005SE |
| K033999 | Sedline with Frontal PsiOLW · Special | 02/06/2004SE |
| K020670 | Model 4310 PSARRAY2 EEG ElectrodeGXY · Special | 10/08/2002SE |
| K020671 | PSA4000 EEG Monitor with Frontal PsiOLW · Special | 10/04/2002SE |
| K001069 | Model 4000 EEG Monitor with Psi (PSA4000)OLW · Traditional | 06/30/2000SE |
| K001055 | Model 4300 Psarray EEG Electrode SetGXY · Traditional | 05/11/2000SE |
| K970942 | Model 1320, Neurolink II Neuromonitoring SystemGWQ · Traditional | 06/02/1997SE |
| K970694 | Model 1700, Hydro PrepGYB · Traditional | 05/14/1997SE |
| K962157 | Model 1310 Neurolink Neuromonitoring SystemGWQ · Traditional | 11/25/1996SE |
| K961609 | Model 1220, or E-Net (54-62 CM)GXY · Traditional | 05/10/1996SE |
Questions and answers
When was Equinox Digital EEG System cleared by the FDA?
Equinox Digital EEG System (K962447) received a 510(k) decision of Substantially Equivalent on December 12, 1996, 171 days after the submission was received.
What is the product code of K962447?
The FDA product code is GWQ – Full-Montage Standard Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.