The following data is part of a premarket notification filed by Ives Eeg Solutions, Inc. with the FDA for Gold Cup Electrode, Silver Cup Electrode And Electrode With Ag-ag/cl Coating And Conductive Plastic Electrode.
| Device ID | K071118 |
| 510k Number | K071118 |
| Device Name: | GOLD CUP ELECTRODE, SILVER CUP ELECTRODE AND ELECTRODE WITH AG-AG/CL COATING AND CONDUCTIVE PLASTIC ELECTRODE |
| Classification | Electrode, Cutaneous |
| Applicant | IVES EEG SOLUTIONS, INC. 6325 RIDEAU VALLEY DRIVE Manotick, Ontario, CA K4m 1b3 |
| Contact | John R Ives |
| Correspondent | John R Ives IVES EEG SOLUTIONS, INC. 6325 RIDEAU VALLEY DRIVE Manotick, Ontario, CA K4m 1b3 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-20 |
| Decision Date | 2007-09-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850012681076 | K071118 | 000 |
| 00850012681229 | K071118 | 000 |
| 00850012681236 | K071118 | 000 |
| 00850012681243 | K071118 | 000 |
| 00850012681250 | K071118 | 000 |
| 00850012681007 | K071118 | 000 |
| 00850012681014 | K071118 | 000 |
| 00850012681021 | K071118 | 000 |
| 00850012681038 | K071118 | 000 |
| 00850012681045 | K071118 | 000 |
| 00850012681052 | K071118 | 000 |
| 00850012681069 | K071118 | 000 |
| 00850012681182 | K071118 | 000 |