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FDA 510(k) Application Details - K152915
Device Classification Name
Nystagmograph
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510(K) Number
K152915
Device Name
Nystagmograph
Applicant
SyncThink, Inc.
54 Canal Street Suite 200
Boston, MA 02114 US
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Contact
Daniel Beeler
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Regulation Number
882.1460
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Classification Product Code
GWN
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More FDA Info for this Product Code
Date Received
10/02/2015
Decision Date
01/29/2016
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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