FDA 510(k) Application Details - K191020

Device Classification Name	More FDA Info for this Device
510(K) Number	K191020
Device Name	G210 InviCell Plus with SignipHy pH monitoring
Applicant	CooperSurgical Inc. 95 Corporate Drive Trumbull, CT 06611 US Other 510(k) Applications for this Company
Contact	Kyle Hooper Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PUB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/17/2019
Decision Date	01/14/2020
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