FDA 510(k) Application Details - K160569

Device Classification Name	More FDA Info for this Device
510(K) Number	K160569
Device Name	NeuGuide
Applicant	POP Medical Solutions 27 Habarzel ST. Tel Aviv 6971039 IL Other 510(k) Applications for this Company
Contact	Guy Ohad Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PBQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/29/2016
Decision Date	07/06/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review