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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 K052904
Device Name VIRTUAL MEDICAL SYSTEMS MODEL VT3000
Applicant
Scientific Imaging, Inc.
110 Bascomb Dr.
Woodstock,  GA  30189
Applicant Contact CHRIS JOHNSON
Correspondent
Intertek Testing Services
70 Codman Hill Rd.
Boxborough,  MA  01719
Correspondent Contact NEIL E DEVINE
Regulation Number882.1550
Classification Product Code
JXE  
Date Received10/14/2005
Decision Date 10/27/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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