The following data is part of a premarket notification filed by Neuro Resource Group, Inc. with the FDA for Interx Sterile Self-adhesive Dual Electrode (issde).
| Device ID | K130816 |
| 510k Number | K130816 |
| Device Name: | INTERX STERILE SELF-ADHESIVE DUAL ELECTRODE (ISSDE) |
| Classification | Electrode, Cutaneous |
| Applicant | NEURO RESOURCE GROUP, INC. 1100 JUPITER RD., STE. 190 Plano, TX 75074 |
| Contact | David Turner |
| Correspondent | David Turner NEURO RESOURCE GROUP, INC. 1100 JUPITER RD., STE. 190 Plano, TX 75074 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-25 |
| Decision Date | 2013-06-21 |
| Summary: | summary |