The following data is part of a premarket notification filed by Neuro-diagnostic Assoc. with the FDA for Medi-dx 7000 Cpt With Amrex Electrodes.
| Device ID | K980866 |
| 510k Number | K980866 |
| Device Name: | MEDI-DX 7000 CPT WITH AMREX ELECTRODES |
| Classification | Stimulator, Electrical, Evoked Response |
| Applicant | NEURO-DIAGNOSTIC ASSOC. 445 DARTMOOR ST. Laguna Beach, CA 92651 |
| Contact | James L Hedgecock, Dc, Phd |
| Correspondent | James L Hedgecock, Dc, Phd NEURO-DIAGNOSTIC ASSOC. 445 DARTMOOR ST. Laguna Beach, CA 92651 |
| Product Code | GWF |
| CFR Regulation Number | 882.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-19 |
| Decision Date | 1998-05-20 |
| Summary: | summary |