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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 K941144
Device Name EXCEL EMG
Applicant
EXCEL TECH. LTD.
2892 PORTLAND DR.
OAKVILLE,ONTARIO,  CA L6H 5W8
Applicant Contact JOHN MUMFORD
Correspondent
EXCEL TECH. LTD.
2892 PORTLAND DR.
OAKVILLE,ONTARIO,  CA L6H 5W8
Correspondent Contact JOHN MUMFORD
Regulation Number890.1375
Classification Product Code
IKN  
Date Received03/10/1994
Decision Date 11/07/1995
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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