The following data is part of a premarket notification filed by Somnitec, Inc. with the FDA for Gold Cup Eeg Cutaneous Electrode W/lead And Ext..
| Device ID | K911989 |
| 510k Number | K911989 |
| Device Name: | GOLD CUP EEG CUTANEOUS ELECTRODE W/LEAD AND EXT. |
| Classification | Electrode, Cutaneous |
| Applicant | SOMNITEC, INC. 7732 BURNET AVE. Van Nuys, CA 91405 |
| Contact | Mark S London |
| Correspondent | Mark S London SOMNITEC, INC. 7732 BURNET AVE. Van Nuys, CA 91405 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-06 |
| Decision Date | 1991-07-30 |