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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 K984052
Device Name SYNERGY IOM SYSTEM
Applicant
OXFORD INSTRUMENTS MEDICAL SYSTEMS
P.O. BOX 4341
CROFTON,  MD  21114
Applicant Contact E J SMITH
Correspondent
OXFORD INSTRUMENTS MEDICAL SYSTEMS
P.O. BOX 4341
CROFTON,  MD  21114
Correspondent Contact E J SMITH
Regulation Number890.1375
Classification Product Code
IKN  
Date Received11/13/1998
Decision Date 05/17/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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