The following data is part of a premarket notification filed by Neuro Resource Group, Inc. with the FDA for Interx5000.
| Device ID | K042912 |
| 510k Number | K042912 |
| Device Name: | INTERX5000 |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | NEURO RESOURCE GROUP, INC. 2220 CHEMSEARCH BLVD. SUITE 108 Irving, TX 75062 |
| Contact | Krista Oakes |
| Correspondent | Krista Oakes NEURO RESOURCE GROUP, INC. 2220 CHEMSEARCH BLVD. SUITE 108 Irving, TX 75062 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-21 |
| Decision Date | 2005-05-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851894007046 | K042912 | 000 |
| 00851894007039 | K042912 | 000 |
| 00851894007022 | K042912 | 000 |
| 00851894007015 | K042912 | 000 |
| 00851894007008 | K042912 | 000 |