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FDA 510(k) Application Details - K110140
Device Classification Name
Stimulator, Electrical, Evoked Response
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510(K) Number
K110140
Device Name
Stimulator, Electrical, Evoked Response
Applicant
NEUROVISION MEDICAL PRODUCTS, INC.
2225 SPERRY AVE, SUITE 1000
VENTURA, CA 93003 US
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Contact
CHRISTINE VERGELY
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Regulation Number
882.1870
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Classification Product Code
GWF
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More FDA Info for this Product Code
Date Received
01/18/2011
Decision Date
09/30/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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