The following data is part of a premarket notification filed by Physiometrix, Inc. with the FDA for Hydrospot Eeg Electrode Model 1501, Hydrospot Leadwire Model 1500.
| Device ID | K960732 |
| 510k Number | K960732 |
| Device Name: | HYDROSPOT EEG ELECTRODE MODEL 1501, HYDROSPOT LEADWIRE MODEL 1500 |
| Classification | Electrode, Cutaneous |
| Applicant | PHYSIOMETRIX, INC. 101 BILLERICA AVE., BLDG. 5 N. Billerica, MA 01862 |
| Contact | Dawn E Frazer |
| Correspondent | Dawn E Frazer PHYSIOMETRIX, INC. 101 BILLERICA AVE., BLDG. 5 N. 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 | 1996-02-22 |
| Decision Date | 1996-04-15 |
| Summary: | summary |