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FDA 510(k) Application Details - K171884
Device Classification Name
Nystagmograph
More FDA Info for this Device
510(K) Number
K171884
Device Name
Nystagmograph
Applicant
Neuro Kinetics, Inc
128 Gamma Dr
Blawnox, PA 15238 US
Other 510(k) Applications for this Company
Contact
Brian Sullivan
Other 510(k) Applications for this Contact
Regulation Number
882.1460
More FDA Info for this Regulation Number
Classification Product Code
GWN
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More FDA Info for this Product Code
Date Received
06/23/2017
Decision Date
11/22/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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