The following data is part of a premarket notification filed by Physiometrix, Inc. with the FDA for E*net Neuromonitoring System.
| Device ID | K930080 |
| 510k Number | K930080 |
| Device Name: | E*NET NEUROMONITORING SYSTEM |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | PHYSIOMETRIX, INC. 575 N. PASTORIA AVE. Sunnyvale, CA 94086 |
| Contact | Christopher R Clare |
| Correspondent | Christopher R Clare PHYSIOMETRIX, INC. 575 N. PASTORIA AVE. Sunnyvale, CA 94086 |
| Product Code | GWQ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-07 |
| Decision Date | 1993-10-19 |