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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electromyograph, diagnostic
510(k) Number K853804
Device Name VICON (MODIFICATION)
Applicant
OXFORD METRICS, INC.
11526 53RD. ST. NORTH
CLEARWATER,  FL  33520
Applicant Contact CRAIG SMITH
Correspondent
OXFORD METRICS, INC.
11526 53RD. ST. NORTH
CLEARWATER,  FL  33520
Correspondent Contact CRAIG SMITH
Regulation Number890.1375
Classification Product Code
IKN  
Date Received09/11/1985
Decision Date 12/27/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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