FDA 510(k) Application Details - K180270

Device Classification Name	Endoscope, Neurological   More FDA Info for this Device
510(K) Number	K180270
Device Name	Endoscope, Neurological
Applicant	Mauna Kea Technologies 9 Rue d'Enghien Paris 75010 FR Other 510(k) Applications for this Company
Contact	Veronique Dentan 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	01/31/2018
Decision Date	05/22/2018
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