The following data is part of a premarket notification filed by Optimit Usa, Inc. with the FDA for Neurology Accessories - Mark-easy 10-20.
| Device ID | K942461 |
| 510k Number | K942461 |
| Device Name: | NEUROLOGY ACCESSORIES - MARK-EASY 10-20 |
| Classification | Electrode, Cutaneous |
| Applicant | OPTIMIT USA, INC. 8522 EAST HELEN PLACE Tucson, AZ 85715 |
| Contact | Marni C Patterson |
| Correspondent | Marni C Patterson OPTIMIT USA, INC. 8522 EAST HELEN PLACE Tucson, AZ 85715 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-24 |
| Decision Date | 1994-10-19 |