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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Electrical, Evoked Response
510(k) Number K931923
Device Name DANTEC MAGLITE MAGNETIC STIMULATOR (MAGLITE)
Applicant
DANTEC MEDICAL, INC.
1575 EYE STREET, N.W.
WASHINGTON,  DC  20005
Applicant Contact RICHARD D MANTHEI
Correspondent
DANTEC MEDICAL, INC.
1575 EYE STREET, N.W.
WASHINGTON,  DC  20005
Correspondent Contact RICHARD D MANTHEI
Regulation Number882.1870
Classification Product Code
GWF  
Date Received04/16/1993
Decision Date 11/09/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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