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FDA 510(k) Application Details - K131434
Device Classification Name
Endoscope, Neurological
More FDA Info for this Device
510(K) Number
K131434
Device Name
Endoscope, Neurological
Applicant
VISIONSENSE, LTD.
555 13TH STREET, NW
WASHINGTON, DC 20004 US
Other 510(k) Applications for this Company
Contact
GERARD J PRUD'HOMME
Other 510(k) Applications for this Contact
Regulation Number
882.1480
More FDA Info for this Regulation Number
Classification Product Code
GWG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/17/2013
Decision Date
07/16/2013
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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