The following data is part of a premarket notification filed by Dantec Electronics, Inc. with the FDA for Dantec 13l35/36/37 Stim. And Recording Electrode.
| Device ID | K874735 |
| 510k Number | K874735 |
| Device Name: | DANTEC 13L35/36/37 STIM. AND RECORDING ELECTRODE |
| Classification | Electrode, Cutaneous |
| Applicant | DANTEC ELECTRONICS, INC. 6 PEARL COURT Allendale, NJ 07401 |
| Contact | Henrik Henriksen |
| Correspondent | Henrik Henriksen DANTEC ELECTRONICS, INC. 6 PEARL COURT Allendale, NJ 07401 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-18 |
| Decision Date | 1988-01-22 |