The following data is part of a premarket notification filed by Physiometrix, Inc. with the FDA for Model 4000 Eeg Monitor With Psi (psa4000).
| Device ID | K001069 |
| 510k Number | K001069 |
| Device Name: | MODEL 4000 EEG MONITOR WITH PSI (PSA4000) |
| Classification | Index-generating Electroencephalograph Software |
| 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 | OLW |
| Subsequent Product Code | OMC |
| Subsequent Product Code | ORT |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-03 |
| Decision Date | 2000-06-30 |