FDA 510(k) Application Details - K190372

Device Classification Name	Hysteroscope (And Accessories)   More FDA Info for this Device
510(K) Number	K190372
Device Name	Hysteroscope (And Accessories)
Applicant	Meditrina, Inc. 1601 S. De Anza Blvd, Suite 165 Cupertino, CA 95014 US Other 510(k) Applications for this Company
Contact	Csaba Truckai Other 510(k) Applications for this Contact
Regulation Number	884.1690   More FDA Info for this Regulation Number
Classification Product Code	HIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/15/2019
Decision Date	05/16/2019
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