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FDA 510(k) Application Details - K192823
Device Classification Name
Stimulator, Electrical, Evoked Response
More FDA Info for this Device
510(K) Number
K192823
Device Name
Stimulator, Electrical, Evoked Response
Applicant
Soterix Medical, Inc.
237 W 35 ST, 1401
New York, NY 10001 US
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Contact
Abhishek Datta
Other 510(k) Applications for this Contact
Regulation Number
882.1870
More FDA Info for this Regulation Number
Classification Product Code
GWF
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More FDA Info for this Product Code
Date Received
10/02/2019
Decision Date
08/13/2021
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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