The following data is part of a premarket notification filed by Physiometrix, Inc. with the FDA for Model 1001, Hydrodot(tm) Neuromonitoring System With E Net(tm) Eeg Interface Cable.
| Device ID | K946318 |
| 510k Number | K946318 |
| Device Name: | MODEL 1001, HYDRODOT(TM) NEUROMONITORING SYSTEM WITH E NET(TM) EEG INTERFACE CABLE |
| Classification | Electrode, Cutaneous |
| Applicant | PHYSIOMETRIX, INC. FIVE BILLERICA PARK 101 BILLERICA AVENUE North Billerica, MA 01862 |
| Contact | Dawn E Frazer |
| Correspondent | Dawn E Frazer PHYSIOMETRIX, INC. FIVE BILLERICA PARK 101 BILLERICA AVENUE North Billerica, MA 01862 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-28 |
| Decision Date | 1995-04-24 |