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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Biofeedback
510(k) Number K912595
Device Name AXIOM ELECTROMYOGRAPH
Applicant
THE COMPUTERIST, INC.
8 FOURTH LN.
POST OFFICE BOX 4131
CHELMSFORD,  MA  01824
Applicant Contact ROBERT M TRIPP
Correspondent
THE COMPUTERIST, INC.
8 FOURTH LN.
POST OFFICE BOX 4131
CHELMSFORD,  MA  01824
Correspondent Contact ROBERT M TRIPP
Regulation Number882.5050
Classification Product Code
HCC  
Date Received06/10/1991
Decision Date 09/06/1991
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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