The following data is part of a premarket notification filed by Physiometrix, Inc. with the FDA for Model 1320, Neurolink Ii Neuromonitoring System.
| Device ID | K970942 |
| 510k Number | K970942 |
| Device Name: | MODEL 1320, NEUROLINK II NEUROMONITORING SYSTEM |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | PHYSIOMETRIX, INC. FIVE BILLERICA PARK, 101 BILLERICA AVE. North Billerica, MA 01862 |
| Contact | Dawn E Frazer |
| Correspondent | Dawn E Frazer PHYSIOMETRIX, INC. FIVE BILLERICA PARK, 101 BILLERICA AVE. North Billerica, MA 01862 |
| Product Code | GWQ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-14 |
| Decision Date | 1997-06-02 |
| Summary: | summary |