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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Nerve Conduction Velocity Measurement
510(k) Number K053058
Device Name XLTEK NEUROPATH, MODEL PK1070
Applicant
Excel Tech. , Ltd.
2568 Bristol Cir.
Oakville,  CA L6H 5S1
Applicant Contact NICOLE LANDREVILLE
Correspondent
Excel Tech. , Ltd.
2568 Bristol Cir.
Oakville,  CA L6H 5S1
Correspondent Contact NICOLE LANDREVILLE
Regulation Number882.1550
Classification Product Code
JXE  
Date Received10/31/2005
Decision Date 02/07/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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