The following data is part of a premarket notification filed by Dantec Medical, Inc. with the FDA for Dantec Magnetic Stimulator Magpro.
Device ID | K926516 |
510k Number | K926516 |
Device Name: | DANTEC MAGNETIC STIMULATOR MAGPRO |
Classification | Stimulator, Electrical, 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 | GWF |
CFR Regulation Number | 882.1870 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-12-30 |
Decision Date | 1993-08-31 |