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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 K880042
Device Name ACUTRON
Applicant
Davis Assoc.
77 Suburban Ave.
Bridgeport,  CT  06604
Applicant Contact PAUL DAVIS
Correspondent
Davis Assoc.
77 Suburban Ave.
Bridgeport,  CT  06604
Correspondent Contact PAUL DAVIS
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received01/05/1988
Decision Date 08/01/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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