The following data is part of a premarket notification filed by Neuro Diagnostics, Inc. with the FDA for Emg/ncv & Evoked Response, Design W/.
| Device ID | K843253 |
| 510k Number | K843253 |
| Device Name: | EMG/NCV & EVOKED RESPONSE, DESIGN W/ |
| Classification | Stimulator, Electrical, Evoked Response |
| Applicant | NEURO DIAGNOSTICS, INC. 111 WEST DYER RD. SUITE F Santa Ana, CA 92707 |
| Product Code | GWF |
| CFR Regulation Number | 882.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-20 |
| Decision Date | 1984-11-20 |