The following data is part of a premarket notification filed by Neuro Resource Group, Inc. with the FDA for Interx500 Flexible Array Electrode.
| Device ID | K053626 |
| 510k Number | K053626 |
| Device Name: | INTERX500 FLEXIBLE ARRAY ELECTRODE |
| Classification | Electrode, Cutaneous |
| Applicant | NEURO RESOURCE GROUP, INC. 1100 JUPITER RD., STE. 190 Plano, TX 75074 |
| Contact | Krista Oakes |
| Correspondent | Krista Oakes 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 | 2005-12-28 |
| Decision Date | 2006-03-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851894007138 | K053626 | 000 |