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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 K012069
Device Name MODIFICATION TO:BREVIO NERVE CONDUCTION TEST INSTRUMENT
Applicant
NEUROTRON MEDICAL, INC.
12300 TWINBROOK PKWY.
SUITE 230
ROCKVILLE,  MD  20852
Applicant Contact WHITT ATHEY
Correspondent
NEUROTRON MEDICAL, INC.
12300 TWINBROOK PKWY.
SUITE 230
ROCKVILLE,  MD  20852
Correspondent Contact WHITT ATHEY
Regulation Number882.1550
Classification Product Code
JXE  
Date Received07/02/2001
Decision Date 08/01/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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