The following data is part of a premarket notification filed by Dantec Medical, Inc. with the FDA for Cantata Emg/evoked Response System.
| Device ID | K896567 |
| 510k Number | K896567 |
| Device Name: | CANTATA EMG/EVOKED RESPONSE SYSTEM |
| Classification | Stimulator, Electrical, Evoked Response |
| Applicant | DANTEC MEDICAL, INC. 777 CORPORATE DR. Mahwah, NJ 07430 |
| Contact | James T Quigley |
| Correspondent | James T Quigley DANTEC MEDICAL, INC. 777 CORPORATE DR. Mahwah, NJ 07430 |
| Product Code | GWF |
| CFR Regulation Number | 882.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-20 |
| Decision Date | 1990-02-16 |