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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Transcutaneous, For Pain Relief
510(k) Number K895473
Device Name DSX(TM), DIGITAL SX, QUANTUM DSX, MODEL 4700S
Applicant
MEDICAL DEVICES, INC.
833 THIRD ST. SOUTHWEST
ST. PAUL,  MN  55112
Applicant Contact BRUCE MACFARLANE,PHD
Correspondent
MEDICAL DEVICES, INC.
833 THIRD ST. SOUTHWEST
ST. PAUL,  MN  55112
Correspondent Contact BRUCE MACFARLANE,PHD
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received09/11/1989
Decision Date 12/08/1989
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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