FDA 510(k) Application Details - K171807

Device Classification Name	More FDA Info for this Device
510(K) Number	K171807
Device Name	ES2 Neuromonitoring Accessory Instruments
Applicant	Stryker Corporation 2 Pearl Court Allendale, NJ 07401 US Other 510(k) Applications for this Company
Contact	Nikin Desai Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PDQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/19/2017
Decision Date	07/18/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review