The following data is part of a premarket notification filed by Dantec Medical, Inc. with the FDA for Dantec Magnetic Stimulator Mag 2 (mag 2).
| Device ID | K902607 |
| 510k Number | K902607 |
| Device Name: | DANTEC MAGNETIC STIMULATOR MAG 2 (MAG 2) |
| Classification | Stimulator, Electrical, Evoked Response |
| Applicant | DANTEC MEDICAL, INC. 1575 EYE STREET, N.W. Washington, DC 20005 |
| Contact | Richard Manthei |
| Correspondent | Richard Manthei DANTEC MEDICAL, INC. 1575 EYE STREET, N.W. Washington, DC 20005 |
| Product Code | GWF |
| CFR Regulation Number | 882.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-12 |
| Decision Date | 1991-05-14 |