The following data is part of a premarket notification filed by Dantec Electronics, Inc. with the FDA for Dantec Counterpoint.
| Device ID | K872106 |
| 510k Number | K872106 |
| Device Name: | DANTEC COUNTERPOINT |
| Classification | Stimulator, Electrical, Evoked Response |
| 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 | GWF |
| CFR Regulation Number | 882.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-01 |
| Decision Date | 1987-09-10 |