FDA 510(k) Application Details - K012069

Device Classification Name Device, Nerve Conduction Velocity Measurement

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510(K) Number K012069
Device Name Device, Nerve Conduction Velocity Measurement
Applicant NEUROTRON MEDICAL, INC.
12300 TWINBROOK PKWY.
SUITE 230
ROCKVILLE, MD 20852 US
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Contact WHITT ATHEY
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Regulation Number 882.1550

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Classification Product Code JXE
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Date Received 07/02/2001
Decision Date 08/01/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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