The following data is part of a premarket notification filed by Dantec Medical, Inc. with the FDA for Dantec Counterpoint Mk2(tm).
| Device ID | K913957 |
| 510k Number | K913957 |
| Device Name: | DANTEC COUNTERPOINT MK2(TM) |
| Classification | Stimulator, Auditory, Evoked Response |
| Applicant | DANTEC MEDICAL, INC. 1575 EYE STREET, N.W. Washington, DC 20005 |
| Contact | Richard D Manthei |
| Correspondent | Richard D Manthei DANTEC MEDICAL, INC. 1575 EYE STREET, N.W. Washington, DC 20005 |
| Product Code | GWJ |
| CFR Regulation Number | 882.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-04 |
| Decision Date | 1992-01-30 |