FDA 510(k) Application Details - K181706

Device Classification Name	Neurological Stereotaxic Instrument   More FDA Info for this Device
510(K) Number	K181706
Device Name	Neurological Stereotaxic Instrument
Applicant	Renishaw Mayfield Sarl 31, Rue Ampere Chassieu 69680 FR Other 510(k) Applications for this Company
Contact	Stephane Vinot Other 510(k) Applications for this Contact
Regulation Number	882.4560   More FDA Info for this Regulation Number
Classification Product Code	HAW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/28/2018
Decision Date	07/26/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review