E*Net Neuromonitoring System
FDA 510(k) K930080 · Physiometrix, Inc.
510(k) numberK930080
Submission
- Device name
- E*Net Neuromonitoring System
- Applicant
- Physiometrix, Inc.
Sunnyvale, CA, US - Received
- January 7, 1993
- Decision date
- October 19, 1993
- 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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| 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 |
| K962447 | Equinox Digital EEG SystemGWQ · Traditional | 12/12/1996SE |
| K962157 | Model 1310 Neurolink Neuromonitoring SystemGWQ · Traditional | 11/25/1996SE |
Questions and answers
When was E*Net Neuromonitoring System cleared by the FDA?
E*Net Neuromonitoring System (K930080) received a 510(k) decision of Substantially Equivalent on October 19, 1993, 285 days after the submission was received.
What is the product code of K930080?
The FDA product code is GWQ – Full-Montage Standard Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.